Identifying the most effective ways to support career development of early stage investigators in clinical and translational science should yield benefits for the biomedical research community. Institutions with Clinical and Translational Science Awards (CTSA) offer KL2 programs to facilitate career development; however, the sustained impact has not been widely assessed.

A survey comprised of quantitative and qualitative questions was sent to 2144 individuals that had previously received support through CTSA KL2 mechanisms. The 547 responses were analyzed with identifying information redacted.

Respondents held MD (47%), PhD (36%), and MD/PhD (13%) degrees. After KL2 support was completed, physicians’ time was divided 50% to research and 30% to patient care, whereas PhD respondents devoted 70% time to research. Funded research effort averaged 60% for the cohort. Respondents were satisfied with their career progression. More than 95% thought their current job was meaningful. Two-thirds felt confident or very confident in their ability to sustain a career in clinical and translational research. Factors cited as contributing to career success included protected time, mentoring, and collaborations.

This first large systematic survey of KL2 alumni provides valuable insight into the group’s perceptions of the program and outcome information. Former scholars are largely satisfied with their career choice and direction, national recognition of their expertise, and impact of their work. Importantly, they identified training activities that contributed to success. Our results and future analysis of the survey data should inform the framework for developing platforms to launch sustaining careers of translational scientists.

The National Clinical and Translational Science Award (CTSA) Consortium 2.0 has developed common metrics as a collaborative project for all participating sites. Metrics address several important aspects and functions of the consortium, including workforce development. The first workforce development metrics to be proposed for all CTSA hubs include the proportion of CTSA-supported trainees and scholars with sustainable careers in translational research and the diversity and inclusiveness of programs.

The University of Utah Center for Clinical and Translational Science (CCTS), a CTSA hub, has been actively engaged in mentoring translational scientists for the last decade. We have developed programs, processes, and institutional policies that support translational scientists, which have resulted in 100% of our KL2 scholars remaining engaged in translational science and in increasing the inclusion of individuals under-represented in medicine in our research enterprise. In this paper, we share details of our program and what we believe are evidence-based best practices for developing sustainable translational research careers for all aspiring junior faculty members.

The University of Utah Center for Clinical and Translational Science has been integral in catalyzing interactions across the campus to reverse the negative trends seen nationally in sustaining clinician scientists. Our programs and processes can serve as a model for other institutions seeking to develop translational scientists.

The Clinical and Translational Science Award (CTSA) Program is a Consortium of nearly 60 academic medical research centers across the USA and a natural network for evaluating the spread and uptake of translational research innovation across the Consortium.

Dissemination of the Accrual to Clinical Trials (ACT) Network, a federated clinical informatics data network for population-based cohort discovery, began January 2018 across the Consortium. Diffusion of innovation theory guided dissemination design and evaluation. Mixed-methods assessed the spread and uptake across the Consortium through July 1, 2019 (n = 48 CTSAs). Methods included prospective time activity tracking (Kaplan–Meier curves), and survey and qualitative interviews.

Within 18 months, nearly 80% of CTSAs had joined the data network and two-thirds of CTSAs achieving technical readiness had initiated launch to local clinical investigators. Over 10,000 ACT Network queries are projected for 2019; and by 2020, nearly all CTSAs will have joined the network. Median time-from-technical-readiness-to-local-launch was 154 days (interquartile range: 87–225 days]. Quality improvement processes reduced time-to-launch by 35.2% (64 days, p = 0.0036). Lessons learned include: (1) conceptualize dissemination as two-stage adoption demonstrating value for both CTSA hub service providers and clinical investigators; (2) include institutional trial into dissemination strategies so CTSA hubs can refine internal workflows and gather local user feedback endorsement; (3) embrace designing-for-dissemination during technology development; and (4) sustain adaptive dissemination and customer relationship management to keep CTSA hubs and users engaged.

Scale-up and spread of the ACT Network provides lessons learned for others disseminating innovation across the CTSA Consortium. The Network is primed for embedded implementation research.

Little is known about designing research recruitment campaigns that connect with underserved, geographically isolated rural populations. A theoretically informed process is needed to assist research teams and practitioners in their evaluation of Facebook’s feasibility as a recruitment tool and development of online materials for recruiting rural adults into healthcare delivery intervention development studies.

We drew from research and theory in communication and incorporated process analysis techniques to develop replicable procedures for designing and evaluating Facebook campaigns for rural recruitment. We describe our process and illustrate using two case studies.

Campaigns received approximately 1000 link clicks from the target rural demographic and successfully enrolled participants using Facebook as a primary method of recruitment. The rural tobacco intervention development study received a total of 477 link clicks, cost only $155.80, and enrolled three (23%) of its 13 participants from Facebook. The rural mental health intervention development study received a total of 518 link clicks, cost only $233.28, and enrolled 178 participants.

Our process yielded two successful recruitment campaigns. Facebook was an affordable and efficacious strategy for enrolling adults in behavioral research studies on tobacco and mental health. Future work should apply these theoretical techniques to additional study topics and evaluate specific message features associated with recruitment.

High impact biomedical research is increasingly conducted by large, transdisciplinary, multisite teams in an increasingly collaborative environment. Thriving in this environment requires robust teamwork skills, which are not acquired automatically in the course of traditional scientific education. Team science skills training does exist, but most is directed at clinical care teams, not research teams, and little is focused on the specific training needs of early-career investigators, whose early team leadership experiences may shape their career trajectories positively or negatively. Our research indicated a need for team science training designed specifically for early-career investigators.

To address this need, we designed and delivered a 2-day workshop focused on teaching team science skills to early-career investigators. We operationalized team science competencies, sought the advice of team science experts, and performed a needs assessment composed of a survey and a qualitative study. Through these multiple approaches, we identified and grouped training priorities into three broad training areas and developed four robust, hands-on workshop sessions.

Attendees comprised 30 pre- and post-doc fellows (TL1) and early-career faculty (KL2 and K12). We assessed impact with a pre- and post-workshop survey adapted from the Team Skills Scale. Results from the pre- and post-test Wilcoxon signed-rank analysis (n = 25) showed statistically significant improvement in team science skills and confidence. Open-ended responses indicated that the workshop focus was appropriate and well targeted to the trainees’ needs.

Although team science education is still very much in its infancy, these results suggest that training targeted to early-career investigators improves team skills and may foster improved collaboration.

The NIH Inclusion Across the Lifespan policy has implications for increasing older adult (OA) participation in research. This study aimed to understand influential factors and facilitators to rural OA research participation.

Thirty-seven rural adults aged ≥66 years participated in focus groups in community centers in four Oregon “non-metro” counties. Transcribed discussions were coded using open-axial coding by an interdisciplinary analytical team.

Ages were 66–96 (mean 82.2) years. Majority were women (64%) and white (86%). Primary, interrelated discussion themes were Motivation and Facilitators, Perceptions of Research, and Barriers to Research Participation. Participants were motivated to engage in research because they believed research had implications for improved longevity and quality of life and potentially benefited future generations. Motivational factors influencing participation included self-benefit and improving others’ lives, opportunities to socialize and learn about current research, research transparency (funding, time commitment, and requirements), and financial compensation. Perceptions influencing trustworthiness in research included funding source (industry/non-industry) and familiarity with the research institution. Barriers to research participation included transportation and concern about privacy and confidentiality. Suggestions for making research participation easier included researchers coming to rural communities and meeting participants in places where OAs gather and providing transportation and hotel accommodations.

Lessons learned offer practical guidance for research teams as they address the new NIH Inclusion Across the Lifespan policy. Including OAs in research in ways that motivate and facilitate participation will be critical for a robust representation across the lifespan and in tailoring treatments to the specific needs of this population.

This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research.

The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group. This group worked with CTSA representatives to tailor competencies and fundamental GCP principles into best practices for social and behavioral research.

Although concepts underlying GCP were deemed similar across all clinical trials, not all areas were equally applicable and the ways in which GCP would be enacted differ for behavioral trials. It was determined that suitable training in best practices for social and behavioral research was lacking.

Based on the training need, an e-learning course for best practices is available to all CTSA sites. Each institution is able to track outcomes for its employees to help achieve standardized competency-based best practices for social and behavioral investigators and staff.

SARS-CoV-2 has been found in the heart of COVID-19 patients. It is unclear how the virus passes from the upper respiratory tract to the myocardium. We hypothesized that SARS-CoV-2 is present in the blood of COVID-19 infected patients, spreading to other organs such as heart.

We targeted two viroporins, Orf3a and E, in SARS-CoV-2. Orf3a and E form non-voltage-gated ion channels. A combined fluorescence potassium ion assay with three channel modulators (4-aminopyridine, emodin-Orf3a channel blocker, and gliclazide-E channel blocker) was developed to detect SARS-CoV-2 Orf3a/E channel activity. In blood samples, we subtracted the fluorescence signals in the absence and presence of emodin/gliclazide to detect Orf3a and E channel activity.

In lentivirus-spiked samples, we detected significant channel activity of Orf3a/E based on increase in fluorescence induced by 4-aminopyridine, and this increase in fluorescence was inhibited by emodin and gliclazide. In 18 antigen/PCR-positive samples, our test results found 15 are positive, demonstrating 83.3% concordance. In 24 antigen/PCR-negative samples, our test results found 21 are negative, showing 87.5% concordance.

We developed a cell-free test that can detect Orf3a/E channel activity of SARS-CoV-2 in blood samples from COVID-19-infected individuals, confirming a hypothesis that the virus spreads to the heart via blood circulation.

Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants.

Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers.

Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers.

Study findings add to literature on research dissemination by documenting health researchers’ perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.

Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP).

Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19.

Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

To assess researchers’ experiences working with community advisory boards (CABs) and perceptions of how community member stakeholder feedback impacted the research.

Individual interviews were conducted with researchers (n= 34) who had presented their research to a Mayo Clinic CAB (at MN, AZ, or FL) from 2014 to 2017, with an average interview duration of 10–15 min. Researchers were asked “In what ways did the feedback you received from the CAB influence your research?” A validated, structured, 7-item interview was used to assess domains of the potential influence that CABs had on the research: (1) pre-research (e.g., generated ideas), (2) infrastructure (e.g., budget preparation), (3) research design, (4) implementation (e.g., research recruitment), (5) analysis, (6) dissemination, and (7) post-research. A total mean score was calculated with a possible range of 0–7. In addition, open-ended examples and feedback from researchers in response to each domain were summarized for themes using content analysis.

Researchers reported that the CAB influenced research in the following domains: pre-research (24%), infrastructure (24%), study design (41%), implementation (41%), analysis (6%), dissemination (24%), and post-research activities (18%). The mean total score was = 1.8 (SD = 1.7, range: 0–6). Open-ended responses revealed major themes of CAB helpfulness in generating/refining ideas, identifying community partners, culturally tailored and targeted recruitment strategies, intervention design and delivery, and dissemination.

Findings from this preliminary evaluation indicate that despite positive experiences noted in open-ended feedback, the perceived quantitative impact of CAB feedback on the research was moderate. Bidirectional communication between researchers and community member stakeholders has the potential to make clinical and translational research more relevant and appropriate.

Translating complex behavior change interventions into practice can be accompanied by a loss of fidelity and effectiveness. We present the evaluation of two sequential phases of implementation of a complex evidence-based community workshop to reduce falls, using the Replicating Effective Programs Framework. Between the two phases, workshop training and delivery were revised to improve fidelity with key elements.

Stepping On program participants completed a questionnaire at baseline (phase 1: n = 361; phase 2: n = 2219) and 6 months post-workshop (phase 1: n = 232; phase 2: n = 1281). Phase 2 participants had an additional follow-up at 12 months (n = 883). Outcomes were the number of falls in the prior 6 months and the Falls Behavioral Scale (FaB) score.

Workshop participation in phase 1 was associated with a 6% reduction in falls (RR = 0.94, 95% CI 0.74–1.20) and a 0.14 improvement in FaB score (95% CI, 0.11– 0.18) at 6 months. Workshop participation in phase 2 was associated with a 38% reduction in falls (RR = 0.62, 95% CI 0.57–0.68) and a 0.16 improvement in FaB score (95% CI 0.14–0.18) at 6 months, and a 28% reduction in falls (RR = 0.72, 95% CI 0.65–0.80) and a 0.19 score improvement in FaB score (95% CI 0.17–0.21) at 12-month follow-up.

Effectiveness can be maintained with widespread dissemination of a complex behavior change intervention if attention is paid to fidelity of key elements. An essential role for implementation science is to ensure effectiveness as programs transition from research to practice.