OBJECTIVES/SPECIFIC AIMS: The proposed pilot study seek to enhance the network of CTSAs at Rockefeller University, NYU, ISMMS, and other community members to support translational workforce development of clinical research nurses and establish a standardized nurse-specific training curriculum in GCP for use within the CTSA network, in other research centers, and in nursing school curricula. This will be coupled with a rigorous evaluation study to test the impact of the training and a comprehensive dissemination plan to make the training available to all nurses and nursing students via modern e-learning method. Aim 1. To create an integrated network of local CTSAs and community partners to develop, validate, and refine a pilot e-learning GCP educational and training program and content and outcomes dissemination plan. It is vital to integrate the efforts of CTSA leaders, community partners, and nursing educators to develop a pilot e-learning nurse workforce training curriculum and the associated evaluation measures and assessment plan. Delphi methods will be employed, coupled with rigorous assessment of face validity, content validity, and item reliability. The resulting educational training program will then be used for an e-learning educational intervention study in CTSAs, other sites, and nursing schools. Aim 2. To test the effect of the pilot GCP education and evaluation program for practicing clinical research nurses (CRNs) within the collaborating CTSAs and community partners, we will perform a randomized controlled trial using a Solomon 4 group design. For the student nurse population, we will develop a randomized control trial using a Solomon 4 group design blocked on course section. As this is a pilot study, descriptive statistics and confidence intervals around parameter estimates will be constructed. In addition, inferential statistics will be calculated on primary outcome of interest (change scores in knowledge of GCP) and measures of heterogeneity of data, patterns of missing data, and reliability of evaluative tools will be analyzed. Aim 3. To implement a dissemination plan to reach both nurses practicing the CRN specialty within CTSAs and other community settings. We will disseminate the program to other CTSAs through the CTSA network communication resources. To broaden the reach to a population of nurses and student nurses with limited prior education or training in nurse-specific GCP competencies, but who provide care to research participants in nontraditional research settings, we will craft a novel set of dissemination methods, including the CITI Program electronic platform that can be accessed by nurses and nursing students across settings. In addition, dissemination will be at nursing education meetings and in nursing journals.METHODS/STUDY POPULATION: There are several components to this pilot program. The component that includes a research strategy is the testing of the effectiveness of the training and educational interventions on GCP knowledge and efficacy. Study cohort: Recruitment of study subjects will be in coordination with 3 CTSA collaborators and community partners for 2 samples: (1) nurses who provide care to clinical research participants across a variety of settings (health care systems, research hospitals, and care provider networks) and who are already trained according to current standard in GCP, (2) nursing students from the collaborative network of the 3 CTSAs, NYU School of Nursing has agreed to pilot test the introductory student module. The methodological approach will be a random assignment control trial Solomon 4 group design for practicing CRNs within the collaborating CTSAs and community partners. For student nurse population, the methodological approach will be a randomized-control trial Solomon 4 group design blocked on course section. Survey measures of CRN GCP knowledge and efficacy will be obtained pre and post educational intervention. RESULTS/ANTICIPATED RESULTS: Aim 1. Expected outcomes are pilot e-learning nurse workforce training modules curriculum, and evaluation measures and plan appropriate for CTSAs, community sites, and nursing schools. Specifically, 14 modules (averaging 30 minutes each) for practicing CRNs, and one 45 minute module for nursing students. The significance of these findings will provide a framework for the e-learning educational intervention study. CITI Program is enthusiastic about the module development and refinement and will provide direction for consistency in formatting with current CITI Program modules, set-up of learner groups for comparison, and evaluative measures such as completion data and scoring. Aim 2. Expected outcomes are an effective pilot educational intervention for practicing nurses and students and valid and reliable evaluation tools and plan that can be generalized to the larger CRN and nursing community. Aim 3. Expected outcomes are an enhanced CTSA dissemination plan that includes non-CTSA resources and reaches non-CTSA employed nurses and nursing students. DISCUSSION/SIGNIFICANCE OF IMPACT: The expected outcomes of this pilot study are: (1) an enduring GCP education that can be continually updated and training structure for CRNs, and nurses and nursing students throughout the United States; (2) a reproducible effective standardized basic nurse-specific GCP curriculum for dissemination; (3) assessment tools to evaluate programmatic success, nurse and nursing student knowledge and efficacy on nurse-specific GCP; (4) and a CTSA dissemination plan that to reach non-CTSA nurses and nursing students. Our ultimate goal is the development of a translational workforce educated and competent in GCP at CTSA sites, at non-CTSA sites, and in nursing schools so as to improve the quality of clinical research.

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

OBJECTIVES/SPECIFIC AIMS: Existing GCP training is geared primarily towards researchers conducting drug, device, or biologic clinical trials, and largely ignores the unique needs of researchers conducting social and behavioral clinical trials. The purpose of this project was to develop a comprehensive, relevant, interactive, and easy to administer GCP eLearning course for social and behavioral researchers. METHODS/STUDY POPULATION: As part of the ECRPTQ project funded by the National Center for Advancing Translational Sciences (NCATS), a Social and Behavioral Work Group of ~30 experienced social and behavioral investigators and study coordinators was formed to develop GCP training for social and behavioral researchers. Existing GCP training programs were reviewed to identify relevant content that should be included as well as gaps specific to social and behavioral clinical trials where new content would need to be developed. In total, 9 specific modules—Introduction, Research Protocol, Roles and Responsibilities, Informed Consent Communication, Confidentiality/Privacy, Recruitment/Retention, Participant Safety/Adverse Event Reporting, Quality Control/Assurance, and Research Misconduct—were identified by the work group and the content was mapped to competency domains defined by the ECRPTQ project, as well as International Council for Harmonisation (ICH) GCP principles. Several investigators and study coordinators were identified as content experts for each module topic. Working with an instructional designer, these experts defined learning objectives and outlined content relevant for both study coordinators and investigators for inclusion in the modules. The curriculum was developed using Articulate Storyline that is SCORM 1.2 compliant making the course usable to the widest audience. The course was designed to be administered on laptop or desktop computers and is accessible for individuals with hearing or viewing impairments. To maximize learning, instructional designers used creative treatments including: narration to guide learners or offer tips; short video scenarios to introduce topics; interactive activities, such as drag and drop games and “click to learn more information”; knowledge checks with feedback; resources, including downloadable job aids; end of module quizzes, and documentation of course completion. The full curriculum takes 2–4 hours to complete, with individual modules taking 30 minutes to complete. RESULTS/ANTICIPATED RESULTS: Pilot testing to evaluate the effectiveness of the eLearning course is underway at 5 sites: University of Michigan, Boston University, University of Rochester, University of Florida, and SUNY Buffalo. DISCUSSION/SIGNIFICANCE OF IMPACT: This eLearning course provides relevant, comprehensive GCP training specifically for social and behavioral researchers. Unlike existing GCP training that is geared towards drug and device researchers, this course includes scenarios and examples that are relevant to social and behavioral researchers. The engaging, interactive nature of this course is designed to improve learning and retention, resulting in improved job performance. In addition, the modules are designed for both investigators and clinical research coordinators, thus eliminating the need for different training modules for different study team members.

OBJECTIVES/SPECIFIC AIMS: Our objectives are to provide opportunities for graduate students, clinical interns, and postdoctoral fellows in traditional training programs to have immersive experiences in clinical research conduct from a CRP perspective. In addition, we aimed to address common causes of job dissatisfaction by providing professional development and networking opportunities for the existing CRP workforce. METHODS/STUDY POPULATION: In collaboration with the CTSA workforce development group, the Duke Office of Clinical Research hosted a site visit for 19 PhD scientists interested in nontraditional career pathways and a short lecture series on project management careers in clinical research. Additionally, we crafted specific clinical research training electives for 20 masters students and 10 dietetic interns. Finally, in collaboration with UNC-CH, we combined Research Professional Networks to provide a pilot joint professional development event for 109 CRPs from both schools. RESULTS/ANTICIPATED RESULTS: The number of Masters students enrolling in the CRP elective grew from 7 students in year 1 to 13 students currently enrolled. A retro-pre/postprogram adapted CRAI survey was issued following program completion. Students self-reported increases in competence across all 24 skills measured. Largest increases were seen in areas specific to CRP roles such as consenting patients, understanding the IRB, and reviewing key study documents. A baseline culture survey issued at the joint Duke/UNC CRP event garnered a 65% response rate and indicated that the principal gaps in professional training are in communications, teamwork, leadership, and professionalism. Moreover, respondents indicated that creating a sense of community and providing networking opportunities were the most important outcomes for future CRP collaborations. Future evaluations of both of these programs will allow us to tailor training to be most effective in strengthening our CRP workforce. DISCUSSION/SIGNIFICANCE OF IMPACT: These initiatives lay the groundwork for the development of a robust training pipeline into CRP careers. Future initiative will apply lessons learned toward creating internship programs aimed at improving diversity and inclusion within these careers. In addition, by addressing the professional development needs of the existing workforce, we create a sustainable environment for well-trained professionals. By evaluating these primary initiatives, we can better define the critical elements that must be included in CRP educational, development, and support programs and subsequently apply these to ultimately improve the clinical and translational research being conducted in academic research settings.

OBJECTIVES/SPECIFIC AIMS: Enhancing Patient Safety for hospitalized patients is a priority for healthcare facilities, providers, and federal funding agencies. Multidisciplinary partnerships in clinical and translational research better defines the scope of complex patient-safety issues, and is part of more effectively developing interventions. The discipline represented by engineering-trained partners brings valuable perspective to patient safety problems through their training background in human factors and systems analysis. The objective of this education program was to create and implement a collaboration between engineering students and clinical providers. Through the Johns Hopkins Institute for Clinical and Translational Research, a multidisciplinary partnership was created, to identify contributing factors, and suggest novel solutions, to key patient safety problems using an ethnographic research approach. METHODS/STUDY POPULATION: The collaboration was formed between the following Johns Hopkins (JH) groups: (1) The Institute for Clinical and Translational Research (ICTR), (2) The Armstrong Institute for Patient Safety, (3) The JH Hospital Clinical Engineering Services, (4) The Homecare Group, (5) The Masters of Science in Engineering Management Program at the Whiting School of Engineering, and (6) The JH Hospital Risk Management. All 6 provided representation to contribute to the planning, structure, and implementation of the project. The initial cohort was 24 masters students enrolled in the JHU Whiting School of engineering, and included 46% men, 54% women, and 75% international students. Students were placed in teams of 2–3 to work on 9 distinct patient safety concerns, as provided by the Armstrong Institute as priority. Potential clinical hosts from the appropriate clinical departments were vetted for feasibility and scope before students were assigned to them. Students and clinical hosts were oriented to the process. The students then spent 3–6 hours a week, for 7 weeks, observing and interacting with patients and health professionals at their specific clinical sites, conducting ethnographic research under the guidance of their hosts. Ethnographic research is the systematic investigation of a culture or system; in our application, teams were looking at the environment, culture, and its contributing factors, with respect to patient safety issues. Teams made observations, then formulated hypothesis and collected data relevant to what systems factors may be contributing to the patient safety issue. Following data collection and analyses, teams made recommendations for culture and/or systems shifts that could impact change and improve patient safety. Ethnography research process training is a tenet of the training undertaken by all Masters of Science in Engineering Management Students. RESULTS/ANTICIPATED RESULTS: At the end of the 7-week project, each team generated a comprehensive report suggesting potential solutions for each problem, and gave presentations on their findings to their peers, clinical hosts, and JHU steering committee representatives. Requirements on the student side included a midterm, final presentation, and report. Both students and site leaders submitted mid- and final program evaluations. Based on follow-up survey data, 71% of students said that the course may impact their career choice, 57% said the collaboration changed the way they viewed themselves, and 28% elected to continue working or were planning to work with their site in some fashion after the course ended. Nearly 60% of students believed additional funding or resources would benefit the course and 71% thought they would benefit from more or similar experiences with their clinical partners. Furthermore, 85% wanted to see the course expanded. Of the clinical hosts, 71% said that students added value, 86% believed students changed their perspective on their problem, unveiled new areas of investigation, and improved or likely would improve patient safety in their department. Seventy-one percent of hosts were actively acting on the students’ findings, and over 86% shared findings with their colleagues. Following the 7-week program, 2 teams also presented their findings to committees within the hospital departments, 2 patient-safety projects are being continued with engineering teams, and 2 new collaborative projects have been initiated. Based on the popularity of this program with the students, hosts, and teaching faculty, this will be implemented within the engineering curriculum for a second time next year. Additional outcomes data collection are currently ongoing, and we plan to continue to monitor and analyze results. DISCUSSION/SIGNIFICANCE OF IMPACT: In its first year our engineering collaboration exceeded expectations. Engineering students and clinical providers successfully worked toward tangible solutions that were directly applicable to patient care. Furthermore, interactions were both personally and professionally beneficial for students while simultaneously adding value to clinical hosts. Beyond the collaboration, this initiative allowed for secondary connections between engineers and clinicians that are also have great potential for resulting in translational innovation. Despite the overwhelming success of this project, it highlighted the need for increased resources for sustainability. Our pilot highlighted a role for funding with regards to: (1) students in the execution of their projects (eg, transportation to sites, prototype materials); (2) clinical hosts, particularly protecting time to interact with and lead student teams; (3) the Armstrong Institute—to aid the identification and prioritization of high impact, patient safety projects; and (4) the ICTR for staff to facilitate placements, student orientation to the hospital setting, and program execution and maintenance. Ultimately, this collaboration addressed an unmet need for the clinical providers as well as the engineering students: thus, all partners agree that (1) the impact of this pilot would be greatly magnified by more time, longer duration, and additional resources; and (2) this collaboration could provide a useful model for approaching other complex health care problems. In terms of larger and longer-term impact, engaging engineers at the training level together with clinicians provides early exposure, and could potentially prime them to continue collaborations with clinical and translational science, across their careers.

Student Research Assistant Acknowledgements: The authors thank Manik Arora, Alexandra Morani, and Thomas Cornish -- Johns Hopkins University.

OBJECTIVES/SPECIFIC AIMS: To diversify the workforce by providing leadership and career coaching training to mentors so that they can be better leaders with their trainees and incorporate career coaching skills into their mentoring style. METHODS/STUDY POPULATION: PROMISED Program helps current and future members of the National Research Mentoring Network (NRMN) develop management, leadership, and career coaching skills so that they may be more effective in guiding their mentees. Studies show that mentees remain engaged in research when they drive their own careers, but mentors rarely help them recognize ways to do this. PROMISED aims to address by providing online leadership training and career coaching training. We developed innovative online leadership training for mentors committed to mentoring people from diverse backgrounds that are focused on management and leadership skills. These modules contain exercises, self-assessments, and discussion boards. We also have reading materials and other supplemental work such as videos to augment the modules. We also created 2-day training on career coaching skills for mentors. Certified career coaches trained participants in career coaching tools so that they could incorporate these skills into their mentoring style. Mentors tend to view themselves as content advisors, and they focus on the next step in the research project rather than the research career. We trained mentors to provide career coaching to their mentees, which will help the mentee establish a successful biomedical research career trajectory. RESULTS/ANTICIPATED RESULTS: In total, 45 mentors attended the Career Coaching Workshop. We assessed 26 mentoring/career coaching traits. Every trait improved on post survey (Likert scale 1–7), for example, “Taking into account the biases and prejudices you bring to the mentor/mentee relationship” (Pre: 4.16, Post: 5.38) and Working with mentees to set clear expectations of the mentoring relationship (Pre: 4.27, Post: 5.32). Some comments from attendees included: “amazing,” “powerful,” “excellent program,” “learned so much.” For the online module, we have a maximum of 20 fellows enrolled in each module. Results show that the fellows rate the module extremely useful. A comment from 1 fellow confirms this: “This session has changed my life and I know that the PROMISED program will transform my abilities as a mentor and as a person.” DISCUSSION/SIGNIFICANCE OF IMPACT: Providing Career Coaching Training and Online leadership skills can significantly improve mentors ability to mentor people, particularly those from diverse backgrounds. In addition, this training can help mentors who are committed to mentoring people from diverse backgrounds promote their own careers as well as their mentees.

OBJECTIVES/SPECIFIC AIMS: Goal—broaden the academic offer to enhance clinical and translational research productivity and cost effectiveness. Objective—implement a distance learning program on conducting proficient research management. METHODS/STUDY POPULATION: Needs assessment attested students’ interest in enrolling and willingness to recruit graduates by the research industry and academia. A master of science in clinical research management and regulatory compliance (MS-CRMRC) was developed using the Core Competency Domains for Clinical Research Professional. Experts from research academia, pharmaceutical industry, composed a Proposal Development Committee. RESULTS/ANTICIPATED RESULTS: Access of a distance learning MS-CRMRC program for students with time constrains. Competent research professional graduates working side by side with the principal investigator on onsite teamwork management, to streamline research processes in compliance to regulations. DISCUSSION/SIGNIFICANCE OF IMPACT: Improvement of clinical and translational research productivity and efficient use of grants funds prevails as a generalized concern. The MS-CRMRC offers an accessible alternative to empower the research enterprise by developing knowledgeable skilled professionals to tackle this need.

OBJECTIVES/SPECIFIC AIMS: To diversify the biomedical research workforce by training postdoctoral scholars and junior faculty from 6 Minority Serving Institutions (MSIs) on practical research skills such as Critical and Creative Thinking, Formulating the Problem, Asking the Right Question, Grant Writing, and Team Science METHODS/STUDY POPULATION: In collaboration with our partners, we identified 11 topics where trainees lack research funding. Next, we identified instructors for these topics. We converted the topics to online module with modules ranging from 2 to 8 weeks. In working with an online education expert, we developed innovative online training using Moodle as the content management system. Scholars complete readings, videos, self-assessments and participate in discussion board each week. In addition, we have weekly synchronous sessions for each module. All scholars are required to take the grant writing module and 8 other modules. After each module, trainees complete a brief survey to evaluate the module. The leaders at the MSI participated in an intensive face-to-face training session on how to be a career coach so that they could be career coaches for the LEADS Scholars at their home institutions. RESULTS/ANTICIPATED RESULTS: In the first year, we selected 13 LEADS Scholars. All but 3 scholars elected to take every module. The 3 scholars did not enroll in the Peer Reviewing module. Results of the brief survey at the end of each module indicate that the scholars value each of the modules and rate them very highly. When 1 scholar wanted to leave the program, we decided to have a conference call with all of the LEADS Scholars to determine what was working and what was not working with the program. All scholars recognized the value of LEADS. Some scholars felt that the weekly synchronous session was too demanding as they have competing demands on their time. We consulted with the leadership at the MSI and decided to modify the requirements of the program such that every synchronous call was not required for successful completion of the module and to earn a badge. Scholars need to have at least 9 badges to earn a certificate. In addition to the training, we decided that scholars would also benefit from mock reviews of their grants. This will help them submit successful grants. We learned that the best way to serve the needs of the scholars is to work iteratively with the scholars and leadership to develop a successful program that most effectively meets their needs of the scholars and helps them launch a successful career. DISCUSSION/SIGNIFICANCE OF IMPACT: Postdoctoral scholars and junior faculty from MSI need practical research training to help launch their research career. We suspect that this is true of many institutions and plan to develop these modules so that they can be widely disseminated to other institutions.

OBJECTIVES/SPECIFIC AIMS: The purpose of this study is to determine if the prevalence of interdisciplinary collaborations has increased over the past 10 years at 1 CTSA-funded institution. METHODS/STUDY POPULATION: We used Scopus to identify all articles published by authors affiliated with any of the Johns Hopkins Institutions for the years 2005, 2010, and 2015. We limited the search by the Scopus Field Codes “Subject Area” to biomedical science only, “Document Type” to articles only, and “Source Type” to journals only. We further eliminated all articles with 1 author or more than 10 authors. This resulted in 2800 articles for 2005, 3987 for 2010, and 4569 for 2015. After exporting the articles, we randomly selected 25 from each of the 3 time periods. Using the World Public Library Outline of Academic Disciplines as a guide, every author was assigned 1 of the following disciplines: Social Science (eg, Psychology), Basic Science (eg, Biology, Chemistry), Agriculture, Computer Science, Engineering, Medicine, Public Health, Nursing, or an Interdisciplinary field (eg, Genetic Medicine) based on their department and school affiliation. Articles with authors who belonged to 1 discipline only were considered single-discipline articles, and articles with authors in a least 2 different disciplines were considered “interdisciplinary.” RESULTS/ANTICIPATED RESULTS: Based on the results of an initial pilot study, in 2005, 24% of articles were interdisciplinary, in 2010, 20% of articles were interdisciplinary, and in 2015, 60% of articles were interdisciplinary. The large gap between the first 2 time periods (2005 and 2010) and the most recent (2015), suggests a possible pattern of increasing growth of interdisciplinary collaborations over time. Expanding this analysis to a much larger sample size will provide additional important evidence. DISCUSSION/SIGNIFICANCE OF IMPACT: Increasing emphasis is being placed on evaluating the effectiveness of the CTSA consortium in achieving its goals and on developing methods to gauge its success. Systematic methods that are easy to replicate across hubs are needed to better understand and track the evolution of scientific collaborations over time. This study outlines a process for determining whether one of the major desirable outcomes of the CTSA, notably the growth of interdisciplinary collaborations, can be determined through the analysis of authorship patterns. Further research is needed to confirm the generalizability of these results across other CTSA hubs.

OBJECTIVES/SPECIFIC AIMS: The prevention, management, and treatment of HIV, STDs, and HCV requires continuous training that reflects contemporary best-practice and innovative care models. In order to improve the NYS AIDS Institute’s comprehensive web-enabled training program, which enhances the capacity of a diverse healthcare workforce, a needs assessment (NA) of our community of practice (CoP) is needed to better understand their training needs, circumstances, and instructional modalities preferences. The goal of the assessment was to better understand our CoP’s preferences of online trainings, and as a result to develop a “responsive design” system that will enhance user’s learning experience thus improving patient care. METHODS/STUDY POPULATION: We developed and deployed an NA survey using REDCap. The instrument consisted in 27 questions related to providers’ preferences on receiving continuing educational training and their use of technologies, including mobile platforms, online modules, webinars, and telehealth. As part of the recruitment strategy, several resources were deployed over a 1-month recruitment period including sequential email blasts, website promotion, and assessment links included in newsletters and social media. Weekly reminders were also used to promote the participation from our CoP. RESULTS/ANTICIPATED RESULTS: A total of 310 respondents participated in the NA, with 85.8% from NYS. 177 were clinicians (20.5% MD, 2.9% PA, 17.3% NP, and 16.3% RN) and 133 nonclinical providers (case/care managers, social workers, public health professionals, coordinators/administrators, and other). The participants worked in hospitals, community health centers, substance use centers, private practices, and state/local health departments. More than 90% of respondents indicated that they preferred both live/in-person and online training, and participants most strongly indicated that they stayed up-to-date on current developments through CDC, the AIDS Institute, and conferences. More than 60% of respondents considered that receiving CE credit for the training was very important and 28% indicated they would use training materials in Spanish if offered. In terms of technology, over 80% of the respondents preferred computers, but more 50% also used mobile devices (computer at home 61.8%, computer at work 85%, tablet 29.9%, iPhone 20.9%, Android 16.6%, other device 2.3%). DISCUSSION/SIGNIFICANCE OF IMPACT: Accessing an online CoP provided a useful opportunity to assess training needs and preferences of clinical and nonclinical providers. Most providers indicated that they were primarily likely to use a work computer to complete online training or secondarily a home computer. With a significant portion of respondents indicating use of tablets, smartphones, and other devices, online training opportunities should be developed with responsive design to assure flexibility and access. In addition to online training, participants indicated that they also strongly valued live, in-person training. Offering training with CDC and the NYS AIDS Institute branding, in Spanish, together with offering continuing education credit, were all seen as desirable training elements. Accessing this online CoP helped streamline and target training priorities and logistics.

OBJECTIVES/SPECIFIC AIMS: The 2 primary objectives were to (i) insure that Scholars can effectively communicate the translational impact of their research to a lay audience and (ii) assess the benefits and efficacy of having community, as well as faculty members, judge the translational impact of KL2 Scholar’s poster presentations. An explicit secondary goal was to further the engagement of community members in CTSI-sponsored translational research. METHODS/STUDY POPULATION: CTSI’s Education, Community Engagement, Discovery and Translation, and Translational Workforce Development Cores created the translational impact questions and evaluation sheets. The Community Engagement and Office of Discovery and Translation recruited community judges from their respective networks and they were assigned to relevant studies. Scholars were provided with the judges scoring template in advance. After the Research Poster Session, the KL2 Scholars evaluated the quality of their presentations and the impact of having feedback from Community Judges. The Community Judges evaluated their perceived “added value” to the research presentations and their interactions with the Scholars. Both Scholars and judges completed evaluations of the poster presentation and judging process, performed on a 5-point Likert scale. RESULTS/ANTICIPATED RESULTS: KL2 Scholars felt that the community impact judges provided valuable feedback on their research (3.8/5) and were satisfied overall with the poster session (3.4/5). In evaluating their own presentations, Scholars tended to rate themselves higher (4.2–4.6/5) on the clarity of their translational impact presentations than the community judges rated the Scholars (4.1–4.2/5). Scholars also rated themselves somewhat higher in the quality of their dealing with any ethical issues and their dissemination plan (4.0/5) than the community judges (3.8/5). Judges were very positive and felt they brought value to the experience (4.2–4.4/5). DISCUSSION/SIGNIFICANCE OF IMPACT: Community judges added qualitative value to the Scholar presentations based on the Scholar and community judge evaluations and based on comparison based on prior year poster sessions. Documenting the degree of impact of the combination of this proscribed poster format and community-judging process awaits future assessment of Scholar presentations before and after the next annual poster presentation.

OBJECTIVES/SPECIFIC AIMS: The goal of this innovative course is to provide community members with sufficient information to either join or decline participation in clinical research. We anticipate that they will gain knowledge in why research is conducted, the ways participants are recruited, the history of research, regulations that guide research today, participant protections, understand the consent process, their risks and benefits of participating in clinical research. METHODS/STUDY POPULATION: We will recruit interested community members via flyers placed at the training location and at other local community centers and agencies that receive heavy foot traffic. The course is listed in the Communiversity catalogue which is distributed in hardcopy (over 30,000) and email each semester. The course will be taught by a longstanding community member and research coordinator at the University of Cincinnati. Each session will be highly interactive including videos, role-play, and discussion of the presented research topics. Evaluation will occur both pre and post-session, along with pre and post-course. RESULTS/ANTICIPATED RESULTS: We anticipate 20–30 participants at each of the 4 sessions. We anticipate that we will learn current perceptions of clinical research and barriers to their participation to enable improved research recruitment. In addition, we will gain new insights into clinical research needs of the community. DISCUSSION/SIGNIFICANCE OF IMPACT: Through these interactive sessions, we will learn why community members participate in research and their barriers to participating. Understanding the perception of research by the target community is critical when developing clinical research recruitment strategies. We will also be developing a more educated community towards clinical research. We will also gain great insight into new clinical research directions as indicated by community members.

OBJECTIVES/SPECIFIC AIMS: The NIH states, “The training of the biomedical workforce has always been an integral part of the NIH mission… It takes just one good mentor to influence the career of a new investigator; it takes a robust culture of mentorship across the research community to strengthen, sustain and diversify the entire biomedical research enterprise.” The University of Minnesota’s CTSI-Education core strives to build and maintain a strong culture of mentoring by providing CTSI KL2 scholars an opportunity to mentor an undergraduate student participating in the Pathways to Research Program (PReP). Using this mentoring model, participants gain valuable benefits and CTSI’s culture of mentoring is strengthened. METHODS/STUDY POPULATION: Participating KL2 scholars are matched with a promising PReP scholar for a 12-week mentored research project. The PReP program selects top candidates through a highly competitive application process. Students work in their mentor’s lab full-time, funded by CTSI-Ed. They engage in additional activities together including a mentor/mentee, an interview activity and 2 social events. Junior faculty scholars are asked to participate as judges at CTSI’s Poster Session and are invited to present at PReP seminars. The program culminates with the announcement of the Junior Mentor of the Year, in which scholars nominate their mentors for the award. Junior faculty mentors receive support through a training course, Optimizing the Practice of Mentoring, mentor orientation and a roundtable discussion with the program director and other mentors. The program’s infrastructure is designed to foster mentee/mentor relationships through faculty and staff support. Junior faculty receive one-on-one coaching when faced with difficult mentoring situations and are recognized for their mentoring successes. RESULTS/ANTICIPATED RESULTS: Junior faculty mentors highly rate the program on the following points; the experience was a good use of time, I am satisfied with my experience, I would recommend this program to faculty colleagues and students. Undergraduates and Professional students rated their mentoring relationship as 1 of 3 best outcomes of the program. In exit surveys, their highly rated program successes include having a network that helps move their career forward, and confidence to persist through training to become a successful researcher. DISCUSSION/SIGNIFICANCE OF IMPACT: Creating a culture of mentoring is important to the strengthen, sustain and diversify the biomedical research workforce. This mentoring model contributes to the mission while vertically integrating CTSI-Ed’s KL2 and PReP programs. On an individual level, junior faculty improve communication and management skills, develop leadership qualities, increase their network, provide a sense of fulfilment and personal growth, and reinforce their own skills and knowledge of subject. They are also provided a top undergraduate student worker fully funded by the program.

OBJECTIVES/SPECIFIC AIMS: Innovation in healthcare is increasingly dependent on technology and teamwork, requiring effective collaboration among diverse disciplines. However, large knowledge barriers exist between these diverse disciplines which hinders effective communication and the innovation processes. We organized an intensive team-based competition event, Sinai MedMaker Challenge, that engaged individuals with a wide range of backgrounds in medicine, biomedical research, computers science, and engineering to collaborate in solving medical problems with technology-based solutions. The learning objectives were to: enable participants to identify healthcare problems which lend themselves to technology-based solutions; delineate key behaviors critical to multidisciplinary team success; identify optimal strategies for communicating in teams; engage and inspire participants to apply knowledge of technology to meaningfully impact clinical care and well-being. METHODS/STUDY POPULATION: The Sinai MedMaker Challenge was a 48-hour team-based competition, modeled after previously held health “hackathons.” Adapting from guidelines provided by MIT Hacking Medicine, the event gathered participants from diverse backgrounds (clinicians, medical students, graduate students in biomedical science and humanities, software developers, engineers, and others), for the purpose of utilizing technology to address pressing problems in the diagnosis, management and/or treatment of pain and/or fatigue. The event flow can be outlined as follows: Phase 1—pre-event brainstorming via Slack and Sparkboard online platforms; Phase 2—problem review with clinical experts; Phase 3—solution pitches, formation of teams, development of prototype solutions; Phase 4—presentations and prizes awarded. The event was sponsored by ISMMS Institutes and Technology Companies. Mentors roamed throughout the event to support the teams in the technical, clinical, and business development aspects of their solutions. RESULTS/ANTICIPATED RESULTS: In total, 78 participants forming 14 teams, worked on the development of software and hardware prototypes (apps/websites, devices, wearables) to address a variety of pain and fatigue problems, culminating in final pitch presentations to a panel of judges comprised of academic experts; innovators and entrepreneurs in the technology start up space. Award recipients were: (1) PT partners, a wearable device for monitoring physical therapy post knee replacement; (2) SickleMeNot, an interactive, multimodal website/app for children designed to assess, monitor and manage pain; and (3) Biolumen, a functional biofeedback system, to treat chronic back pain. Evaluations revealed a high-degree of satisfaction with the event. Several teams continue to develop their prototypes. DISCUSSION/SIGNIFICANCE OF IMPACT: The Sinai MedMaker Challenge (1) was a compelling and productive forum to bring together students, trainees, faculty and other stakeholders to explore tech-based solutions for management, monitoring, and treatment of pain and fatigue; and (2) can be repeated annually, fostering a “Community of Practice,” and expanded to offer pre and post event opportunities to encourage iterative learning and ongoing creative output.

OBJECTIVES/SPECIFIC AIMS: Develop a plain language informed consent template that met IRB and regulatory requirements. Evaluate the effectiveness of the template at improving the readability of informed consents. Field test the informed consent with low health literacy. METHODS/STUDY POPULATION: We conducted a retrospective analysis of over 200 UAMS IRB approved, investigator initiated informed consents from 2013 to 2015 to determine the readability before intervention. The mean grade level readabilities were derived from the results of 3 readability formulas (Flesch-Kincaid, SMOG, and Fry) using open-source readability tools. A plain language informed consent template that meets IRB and regulatory requirements was developed, adhering to health literacy best practices for written communication. The template was made available to investigators as an optional resource, and IRB committees were trained on use of the template. In addition, a focus group will be conducted to qualitatively assess understandability of the template with study participants identified as having inadequate health literacy. Data analysis will include readability assessment of IRB approved informed consents post intervention with and without use of the plain language template, as well as qualitative feedback from focus group participants. RESULTS/ANTICIPATED RESULTS: The retrospective analysis revealed a mean readability of 10th grade for IRB approved informed consents from 2013 to 2015 (n=217). The readability of the developed plain language template was 5th grade. Preliminary post-intervention results show adoption of the template by investigators (n=16) resulted in informed consents with a mean readability of 7th grade (range 6–9th grade), compared to a mean of 10th grade (range 7–11th grade) for the comparator (“no adoption” group, n=24). Data collection will continue through May 2017. The focus group is forthcoming and results will be included in the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Low health literacy is common in individuals with healthcare disparities and can limit their participation in clinical research. Few studies have examined interventions to address this barrier to research. Preliminary results of this study support the utilization of a plain language informed consent template in investigator-initiated research. Moreover, this study demonstrates the importance of stakeholder engagement among CTSA leadership, health literacy experts, the institutional review board, investigators, and research subjects in the development and testing of this intervention to make informed consents “understandable to the subject” while containing all required elements.

OBJECTIVES/SPECIFIC AIMS: Exposure to theatrical performances holds promise for addressing bioethical issues, but there has been little empirical examination of the impact of dramatic presentation on audiences’ attitudes. This study assessed the short-term impact of the play, Informed Consent, on perceptions of trust, willingness to donate biospecimens, attitudes toward harm and privacy among the general public and in faculty, medical and undergraduate students within an academic medical center in the intermountain west. METHODS/STUDY POPULATION: Surveys were administered before and after a staged reading of the play by professional actors. Pre and post survey responses were linked for each participant. Survey items included the short form Trust in Medical Researchers, and single item questions about group identity, of genetic testing in children, and willingness to donate biospecimens. In total, 3 additional questions about harm, consent, and ethical investigator behavior as represented in the play were asked in the post survey. In addition, respondents were given the option to answer open-ended questions through email. RESULTS/ANTICIPATED RESULTS: Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online ~1 week after the play. Across all participants, there were significant declines for Trust in Medical Researchers and for the survey item “is it ethical for genetic testing in children for adult onset conditions,” (p<0.001 for both) following the play. There was a significant increase in agreement to improve group identity protections (p<0.001) and no differences on willingness to donate biospecimens to research (p=0.777). When differences were analyzed by race of the participant, non-White participants (n=68) compared with White participants (n=344) were less willing to donate biospecimens in general (p<0.001). Further, non-White participants’ willingness to donate biospecimens decreased (p=0.049) after viewing the play while the white participants’ willingness to donate was unchanged. Qualitative data provided extensive contextual data supporting these perspectives. DISCUSSION/SIGNIFICANCE OF IMPACT: This is one of the first studies to empirically examine the impact of a theatrical performance on both attitudes and behavioral intentions toward research and clinical research participation. Some attitudes changed following the play performance, but there were no significant differences on intention to donate biospecimens for research overall. Future research can further address the value and impact of theatrical performances and other creative arts as tools to engage the public and investigators in dialogue about the ethical issues and complexities in clinical research and further evaluation of the impact of performances on attitudes about research and ethics. Creative arts may be used to motivate investigators and study participants to confront fundamental questions about research participation and trust.

OBJECTIVES/SPECIFIC AIMS: The purpose of this descriptive study is to explore knowledge, attitudes, and behaviors related to genetics and genetic research in a sample of persons of African descent. METHODS/STUDY POPULATION: Data were generated using a cross-sectional survey design. A nonprobability sample of 272 persons of African descent, ages 18 and older, were recruited from the Washington, DC metropolitan area through public advertisement and word-of-mouth. Participants had diverse backgrounds with most born in the United States (93%), female (71%), some college or above education (57%), household income under $40,000 (54%), and some with a reported disability (38%). Before survey recruitment and administration, this study was reviewed and approved by the Howard University Institutional Review Board. RESULTS/ANTICIPATED RESULTS: The majority (79.8%) of the participants considered themselves as having a “fair” to “good” knowledge of genetics. The sample had a 2.24 (SD=77) mean score on the 5-item genetics knowledge questionnaire with total possible mean scores ranging from 0 (no correct responses) to 5 (all correct responses). Most (53.3%) participants believe it is important for persons of African descent to participate in genetic research. However, almost one-half (46.7%) felt that information from genetic research can be used to discriminate against minorities. In terms of behaviors, 83.4% of the participants never had genetic testing conducted. However, an overwhelming majority reported that they would be willing to participate in a genetic research project specifically for detection of risk factors such as cancer (87%), diabetes (89.3%), Alzheimer disease (88.6%), and alcohol use disorder (75%). DISCUSSION/SIGNIFICANCE OF IMPACT: This investigation suggests that persons of African descent generally view participation in genetic research as important and are willing to have their genetic profile analyzed to detect susceptibility to certain diseases. However, ethical issues, such as misuse of genetic research to discriminate against minorities, remain a prominent concern. Further studies are needed to illuminate KABEs and to help identify the role these factors may play in this population’s willingness to participate in testing and research. Such information could provide invaluable insight to the development and implementation of more ethical and culturally competence strategies for recruiting minority participants into genetic research.

OBJECTIVES/SPECIFIC AIMS: The objectives of this study were (1) to examine research participant levels of satisfaction, experiences, and perceptions; and (2) to determine best practices for researchers for engaging research volunteers in clinical trials, and thereby reducing barriers to participation. METHODS/STUDY POPULATION: A self-administered IRB approved survey on satisfaction and perceptions of research participants in clinical and translational studies was developed. The study questions were validated by 5 key informants from each of the 3 research centers who were asked to provide constructive feedback on the clarity and relevance of the questions. The final survey was a 25-item questionnaire that used a Likert scale and focused on 5 domains to reflect satisfaction with “Staff delivery of care,” “Environment,” “Center Operations,” “Study specific questions,” and “overall experiences.” Questions to reflect participant perceptions were open ended. A convenience sample of all participants currently enrolled in research studies at CTSA institutions (GU, HU, and MHRI) was obtained. In total, 131 participants completed the survey. Of these, 15 were “surrogate” partners. RESULTS/ANTICIPATED RESULTS: Eighty-two (60%) of the participants were African Americans, 40 (29%) were Whites; 94 (67%) were first time study participants. Over 90% of those surveyed strongly agreed that they were “treated well,” that their “privacy was respected,” and that they “felt comfortable asking questions of the staff.” Eighty-four percent indicated they would participate in future studies while over 91% indicated they would recommend a family member or a friend. Only 46% of participants coming for their first research visit strongly agreed that the “compensation received was satisfactory.” However, 74% of participants returning for follow-up or who had been enrolled in a previous study felt the compensation was appropriate. Seventy-four percent of those enrolled for the first time indicated “knowing the duration of this study” as compared with only 38% of repeat visitors. When asked what they liked most about participating in a research study their primary responses were “contribution to science” and “knowledge about their diseases.” Conversely, when asked what they liked least about the study they responded that the blood draws were uncomfortable and there were often barriers to transportation and parking. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this survey demonstrated that the majority of research participants rate their experience as highly favorable even among those who had never participated in clinical research previously. In some existing literature, it has been reported that financial compensation was a major motivation to participation in studies involving healthy volunteers. In this current study, however, financial compensation did not appear to be the primary motivation for participation. The participants’ at all 3 sites stated that the main reason for their participation was the increased knowledge about their disease and the contribution to science. Negative experiences cited were primarily discomfort with blood draw, transportation, and parking logistics. Most importantly, a majority of the participants stated they would participate in future studies and would recommend a family member or a friend for a clinical study. In our sample, there was no difference in the favorable ratings as determined by race/ethnicity. In conclusion, the findings of this study inform the community with regard to how the research participants rate their experiences, and thus motivate others to participate in clinical research. Reasons for participants to withdraw from trials may be associated to their dissatisfaction with a trial or with the study staff. Thus, the degree of satisfaction with the research staff and the trial itself is crucial to reducing drop-out rates and increasing compliance with study procedures. Hence participant satisfaction is key to increasing participation in clinical trials, particularly among African Americans and other racial and ethnic minorities.

OBJECTIVES/SPECIFIC AIMS: Discuss ethical and policy issues that will impact clinical research. Raise awareness of the need to understand internal policies at home institutions Encourage further examination of ways to facilitate clinical research participation. METHODS/STUDY POPULATION: Ethical and policy analysis. RESULTS/ANTICIPATED RESULTS: Ideally, clinical research participants should not be required to pay to participate in research. However, if we go with an equity model, as opposed to an equality model, policies should be changed to allow equal access to research participation. This is a matter of justice and also will enhance the quality of the science. DISCUSSION/SIGNIFICANCE OF IMPACT: Unless steps are taken to make participation in clinical research less burdensome financially for participants, research may slow or results may be biased, because only those who can pay will be able to participate.

OBJECTIVES/SPECIFIC AIMS: The Institute for Transnational Sciences (ITS) has developed novel methods to ethically engage stakeholders across the transnational research spectrum, up to and including public health practice and policy. METHODS/STUDY POPULATION: In 2014, the ITS co-founded The Research, Education, And Community Health (REACH), the mission of which was to facilitate communication, collaborative research, and service activities between faculty and scientists and area community leaders. The intent was to identify and meet the needs of our communities without gaps and/or redundancies, thus better leveraging time, funding, and efforts. RESULTS/ANTICIPATED RESULTS: REACH now boasts 23 Centers, Departments, and Institutes, as well as 39 community organizations, including public and mental health agencies, clinicians, policy makers, family service centers, cultural and faith-based organizations, business, and local schools/colleges. We offer 3 methods for consideration as best practices: (1) a comprehensive community health needs assessment, (2) an “Offer and Ask” community/campus partnership mechanism, and (3) Community Science Workshops, based on the European Union’s Science Shops. DISCUSSION/SIGNIFICANCE OF IMPACT: Results of REACH’s work have been used to provide guidance for enhanced, data-driven programs and allocation of resources for local and statewide initiatives. The organization has evolved into an independent coalition seeking 501(c)3 status and is planning to expand its scope to 5 counties. REACH thus serves as model for successful replication across applicable CTSA hubs.