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.

Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial.

The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation.

All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources.

Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.

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.

Biomedical researchers need skills in innovation and entrepreneurship (I&E) to efficiently translate scientific discoveries into products and services to be used to improve health.

In 2016, the European Union identified and published 15 entrepreneurial competencies (EntreComp) for the general population. To validate the appropriateness of these competencies for I&E training for biomedical researchers and to identify program content, we conducted six modified Delphi panels of 45 experts (6–9 per panel). Participating experts had diverse experience, representing such fields as entrepreneurship, academic research, venture capital, and industry.

The experts agreed that all 15 EntreComp competencies were important for biomedical research trainees and no additional competencies were identified. In a two-round Delphi process, the experts identified 120 topics to be included in a training curriculum. They rated the importance of each topic using a 5-point scale from not at all important (1) to extremely important (5) for two student groups: entrepreneurs (those interested in starting their own ventures) and intrapreneurs (those wanting to be innovative and strategic within academia or industry). Consensus (mean importance score >4) was reached that 85 (71%) topics were of high importance for the curriculum. Four topics were identified by multiple panels for both student groups: resiliency, goal setting, team management, and communication skills.

I&E training for biomedical trainees should address all 15 EntreComp competencies, including “soft skills,” and be flexible to accommodate the needs of trainees on different career trajectories.

Communities of color have faced disproportionate morbidity and mortality from COVID-19, coupled with historical underrepresentation in US clinical trials, creating challenges for equitable participation in developing and testing a safe and effective COVID-19 vaccine.

To increase diversity, including racial and ethnic representation, in local Los Angeles County NIH-sponsored Phase 3 SARS-CoV-2 vaccine clinical trials, we used deliberative community engagement approaches to form a Community Consultant Panel (CCP) that partnered with trial research teams. Thirteen members were recruited, including expertise from essential workers, community-based and faith-based organizations, or leaders from racial and ethnic minority communities.

Working closely with local investigators for the vaccine studies, the CCP provided critical insight on best practices for community trust building, clinical trial participation, and reliable information dissemination regarding COVID-19 vaccines. Modifying recruitment, outreach, and trial protocols led to majority–minority participants (55%–78%) in each of the three vaccine clinical trials. CCP’s input led to cultural tailoring of recruitment materials, changes in recruitment messaging, and supportive services to improve trial accessibility and acceptability (transportation, protocols for cultural competency, and support linkages to care in case of an adverse event). Barriers to clinical trial participation unable to be resolved included childcare, requests for after-hours appointment availability, and mobile locations for trial visits.

Using deliberative community engagement can provide critical and timely insight into the community-centered barriers to COVID-19 vaccine trial participation, including addressing social determinants of health, trust, clinical trial literacy, structural barriers, and identifying trusted messenger and reliable sources of information.

Unmet social needs contribute to growing health disparities and rising health care costs. Strategies to collect and integrate information on social needs into patients’ electronic health records (EHRs) show promise for connecting patients with community resources. However, gaps remain in understanding the contextual factors that impact implementing these interventions in clinical settings.

We conducted qualitative interviews with patients and focus groups with providers (January−September 2020) in two primary care clinics to inform the implementation of a module that collects and integrates patient-reported social needs information into the EHR. Questions addressed constructs within the Theoretical Framework for Acceptability and the Consolidated Framework for Implementation Research. Data were coded deductively using team-based framework analysis, followed by inductive coding and matrix analyses.

Forty patients participated in interviews, with 20 recruited at the clinics and 20 from home. Two focus groups were conducted with a total of 12 providers. Factors salient to acceptability and feasibility included patients’ discomfort answering sensitive questions, concerns about privacy, difficulty reading/understanding module content, and technological literacy. Rapport with providers was a facilitator for patients to discuss social needs. Providers stressed that limited time with patients would be a barrier, and expressed concerns about the lack of available community resources.

Findings highlight the need for flexible approaches to assessing and discussing social needs with patients. Feasibility of the intervention is contingent upon support from the health system to facilitate social needs assessment and discussion. Further study of availability of community resources is needed to ensure intervention effectiveness.

The Institute of Translational Health Sciences (ITHS), a Clinical and Translational Science Award (CTSA)-funded program at the University of Washington (UW), established the Drug and Device Advisory Committee (DDAC) to provide product-specific scientific and regulatory mentoring to investigators seeking to translate their discoveries into medical products. An 8-year retrospective analysis was undertaken to evaluate the impact of the DDAC programs on commercialization metrics.

Tracked metrics included the number of teams who consulted with the DDAC, initiated a clinical trial, formed a startup, or were successful obtaining federal small business innovation awards or venture capital. The review includes historical comparisons of the startup rates for the UW School of Medicine and the Fred Hutchinson Cancer Research Center, two ITHS-affiliated institutions that have had different DDAC utilization rates.

Between 2008 and 2016, the DDAC supported 161 unique project teams, 28% of which went on to form a startup. The commercialization rates for the UW School of Medicine increased significantly following integration of the DDAC into the commercialization programs offered by the UW technology transfer office.

A formalized partnership between preclinical consulting and the technology transfer programs provides an efficient use of limited development funds and a more in-depth vetting of the business opportunity and regulatory path to development.

Effective translational research requires engagement and collaboration between communities, researchers, and practitioners. We describe a community scientist academy (CSA) developed at the suggestion of our Clinical and Translational Science Awards’ (CTSA) community advisory board to engage and capacitate community members by (1) increasing community members’ and patients’ understanding about the research process and (2) increasing their access to opportunities to influence and participate in research. A joint CTSA/community planning committee developed this 8-hour workshop including sessions on: (1) research definitions and processes; (2) study design; (3) study implementation; and (4) ways to get involved in research. The workshop format includes interactive exercises, content slides and videos, and researcher and community presenters.

Community-based information sessions allowed assessment of community interest before piloting. Two pilots of the CSA were conducted with community members and patients. Participant data and a pre/post knowledge and feedback survey provide evaluation data.

The pilot included 24 diverse participants, over half of whom had not previously participated in research. Evaluation data suggest knowledge gains. Post-CSA, one-third have reviewed CTSA pilot grants and over 80% want to attend further training.

The CSA can demystify the research process for those underrepresented in research and facilitate their engagement and influence within CTSAs.

Growing recognition that collaboration among scientists from diverse disciplines fosters the emergence of solutions to complex scientific problems has spurred initiatives to train researchers to collaborate in interdisciplinary teams. Evaluations of collaboration patterns in these initiatives have tended to be cross-sectional, rather than clarifying temporal changes in collaborative dynamics. Mobile health (mHealth), the science of using mobile, wireless devices to improve health outcomes, is a field whose advancement needs interdisciplinary collaboration. The NIH-supported annual mHealth Training Institute (mHTI) was developed to meet that need and provides a unique testbed.

In this study, we applied a longitudinal social network analysis technique to evaluate how well the program fostered communication among the disciplinarily diverse scholars participating in the 2017−2019 mHTIs. By applying separable temporal exponential random graph models, we investigated the formation and persistence of project-based and fun conversations during the mHTIs.

We found that conversations between scholars of different disciplines were just as likely as conversations within disciplines to form or persist in the 2018 and 2019 mHTI, suggesting that the mHTI achieved its goal of fostering interdisciplinary conversations and could be a model for other team science initiatives; this finding is also true for scholars from different career stages. The presence of team and gender homophily effects in certain years suggested that scholars tended to communicate within the same team or gender.

Our results demonstrate the usefulness of longitudinal network models in evaluating team science initiatives while clarifying the processes driving interdisciplinary communications during the mHTIs.

MD-PhD training programs train physician-scientists to pursue careers involving both clinical care and research, but decreasing numbers of physician-scientists stay engaged in clinical research. We sought to identify current clinical research training methods utilized by MD–PhD programs and to assess how effective they are in promoting self-efficacy for clinical research.

The US MD–PhD students were surveyed in April–May 2018. Students identified the clinical research training methods they participated in, and self-efficacy in clinical research was determined using a modified 12-item Clinical Research Appraisal Inventory.

Responses were received from 61 of 108 MD–PhD institutions. Responses were obtained from 647 MD–PhD students in all years of training. The primary methods of clinical research training included no clinical research training, and various combinations of didactics, mentored clinical research, and a clinical research practicum. Students with didactics plus mentored clinical research had similar self-efficacy as those with didactics plus clinical research practicum. Training activities that differentiated students who did and did not have the clinical research practicum experience and were associated with higher self-efficacy included exposure to Institutional Review Boards and participation in human subject recruitment.

A clinical research practicum was found to be an effective option for MD–PhD students conducting basic science research to gain experience in clinical research skills. Clinical research self-efficacy was correlated with the amount of clinical research training and specific clinical research tasks, which may inform curriculum development for a variety of clinical and translational research training programs, for example, MD–PhD, TL1, and KL2.

The need to diversify the biomedical research workforce is well documented. The importance of fostering the careers of fledgling underrepresented background (URB) biomedical researchers is evident in light of the national and local scarcity of URB scientists in biomedical research. The Career Education and Enhancement for Health Care Research Diversity (CEED) program at the University of Pittsburgh Institute for Clinical Research Education (ICRE) was designed to promote career success and help seal the “leaky pipeline” for URB researchers. In this study, we aimed to quantify CEED’s effect on several key outcomes by comparing CEED Scholars to a matched set of URB ICRE trainees not enrolled in CEED using data collected over 10 years.

We collected survey data on CEED Scholars from 2007 to 2017 and created a matched set of URB trainees not enrolled in CEED using propensity score matching in a 1:1 ratio. Poisson regression was used to compare the rate of publications between CEED and non-CEED URB trainees after adjusting for baseline number of publications.

CEED has 45 graduates. Seventy-six percent are women, 78% are non-White, and 33% are Hispanic/Latino. Twenty-four CEED Scholars were matched to non-CEED URB trainees. Compared to matched URB trainees, CEED graduates had more peer-reviewed publications (p=0.0261) and were more likely to be an assistant professor (p=0.0145).

Programs that support URB researchers can help expand and diversify the biomedical research workforce. CEED has been successful despite the challenges of a small demographic pool.