The Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course.

Participants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted.

Participants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later.

The course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

Effective patient engagement is central to patient-centered outcomes research. A well-designed infrastructure supports and facilitates patient engagement, enabling study development and implementation. We sought to understand infrastructure needs from recipients of Patient-Centered Outcomes Research Institute (PCORI) pilot grant awards.

We surveyed recipients of PCORI pilot project awards on self-perceived strengths in engagement infrastructure through PCORI’s Ways of Engaging-Engagement Activity Tool survey, and interviewed leaders of 8 projects who volunteered as exemplars. Descriptive statistics summarized the survey findings. We conducted a thematic analysis of the interview transcripts.

Of the 50 surveyed pilots, 22 answered the engagement infrastructure questions (44% response rate). Survey and interview findings emphasized the importance of committed institutional leadership, ongoing relationships with stakeholder organizations, and infrastructure funding through Clinical and Translational Science Awards, PCORI, and institutional discretionary funds.

These findings highlight the importance of and how to improve upon existing institutional infrastructure.

To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.

Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.

Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.

Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

The Certificate Program in Translational Research (CPTR) at the Georgia Clinical and Translational Science Alliance provides Ph.D. students, postdoctoral fellows and faculty with didactic, mentored, and experiential training in clinical and translational research.

Quantitative evaluation includes tracking trainee competency, publications, grants and careers in clinical and translational research. Qualitative evaluation includes interviews with trainees about program experiences.

The CPTR provided knowledge and skills in clinical and translational research through coursework, clinical rotations, and collaboration with interdisciplinary scientists. Trainees reported increased confidence in 22 program competencies. Trainees have published more than 290 peer-reviewed articles and received over $4 million in grants from the NIH, over $15 million from the U.S. Department of Defense, and more than $300,000 from foundations. Trainees who completed the program remained in clinical and translational research.

Programs like the CPTR are needed to train investigators to advance biomedical discoveries into population health.

The Latino population in the United States is rapidly growing and faces profound health disparities; however, engagement of Latinos in biomedical research remains low. Our community-based participatory research partnership has recruited 2083 Spanish-speaking Latinos into 21 studies over 15 years. We sought to identify and describe the strategies we have used to successfully recruit and retain Spanish-speaking Latinos in research.

We abstracted and analyzed data from archived study notes, progress reports, team meeting minutes, and in-depth interviews conducted annually from community-based participatory research partnership members. We used a nominal group process to refine and prioritize strategies.

Overall, 13 recruitment strategies and 12 retention strategies emerged. These strategies relied on the creativity and perseverance of the study team and partners.

It is essential that we develop and disseminate effective recruitment and retention strategies that engage Latinos in biomedical research to reduce health disparities and promote health equity.

Early life exposures affect health and disease across the life course and potentially across multiple generations. The Clinical and Translational Research Institutes (CTSIs) offer an opportunity to utilize and link existing databases to conduct lifespan research.

A survey with Lifespan Domain Taskforce expert input was created and distributed to lead lifespan researchers at each of the 64 CTSIs. The survey requested information regarding institutional databases related to early life exposure, child-maternal health, or lifespan research.

Of 64 CTSI, 88% provided information on a total of 130 databases. Approximately 59% (n=76/130) had an associated biorepository. Longitudinal data were available for 72% (n=93/130) of reported databases. Many of the biorepositories (n=44/76; 68%) have standard operating procedures that can be shared with other researchers.

The majority of CTSI databases and biorepositories focusing on child-maternal health and lifespan research could be leveraged for lifespan research, increased generalizability and enhanced multi-institutional research in the United States.

The Clinical and Translational Science Award (CTSA) institutions are increasing development of training programs in community-engaged research (CEnR) to support translational science.

This study sampled posters at CTSA national meetings to identify CEnR training approaches, topics, and outcomes.

Qualitative analysis of 30 posters revealed training topics and outcomes focused primarily on CEnR capacity building, overcoming barriers, systems change, and sustainability.

Further research should focus on development and results of CTSA CEnR training program metrics.

There is growing concern about the declining physician-scientist workforce. NIH recently provided a national dashboard describing the biomedical research workforce, but local strategies are needed.

We used curated local and national data to develop a workforce dashboard.

Many trends at Oregon Health & Science University (OHSU) were similar to those nationally, such as the increasing percentage of Research Project Grant (RPG)-holding PhDs and the aging RPG population, but differences were also apparent. At OHSU, nearly ¾ of physician-scientist RPGs hold MD-only, compared with nationally, where nearly half are MD/PhD. OHSU also lags in the percentage of RPGs held by women physician-scientists.

Our analysis also permitted us to gain a more complete picture of research funding that has been done nationally. We used these data to develop a dashboard that allows our institution to develop policies to increase the numbers of physician-scientists. The data generation approaches and dashboard are likely to be useful at other institutions, as well.

Little is known about what motivates people to enroll in research registries. The purpose of this study is to identify facilitators of registry enrollment among diverse older adults.

Participants completed an 18-item Research Interest Assessment Tool. We used logistic regression analyses to examine responses across participants and by race and gender.

Participants (N=374) were 58% black, 76% women, with a mean age of 68.2 years. All participants were motivated to maintain their memory while aging. Facilitators of registry enrolled varied by both race and gender. Notably, blacks (estimate=0.71, p<0.0001) and women (estimate=0.32, p=0.03) were more willing to enroll in the registry due to home visits compared with whites and men, respectively.

Researchers must consider participant desire for maintaining memory while aging and home visits when designing culturally tailored registries.

Formal training in team leadership is not taught in biomedical research graduate training programs or medical schools.

We piloted a Leadership Training Workshop for graduate biomedical and medical students enrolled in our Interprofessional Research Design Course.

The Kane–Baltes self-efficacy survey demonstrated improved leadership skills (median scores pretraining and post-training were 71 and 76.6; paired t-test, p=0.04).

Most students demonstrated significant improvement in self-awareness pertaining to their own innate leadership styles.

We developed a service to identify potential study participants through electronic medical records and deliver study invitations through patient portals.

The service was piloted in a cohort study that used multiple recruitment methods.

Patient portal messages were sent to 1303 individuals and the enrollment rate was 10% (n=127). The patient portal enrollment rate was significantly higher than email and post mail (4%) strategies.

Patient portal messaging was an effective recruitment strategy.

The patient portal may be an effective method for administering surveys regarding participant research experiences but has not been systematically studied.

We evaluated 4 methods of delivering a research participant perception survey: mailing, phone, email, and patient portal. Participants of research studies were identified (n=4013) and 800 were randomly selected to receive a survey, 200 for each method. Outcomes included response rate, survey completeness, and cost.

Among those aged <65 years, response rates did not differ between mail, phone, and patient portal (22%, 29%, 30%, p>0.07). Among these methods, the patient portal was the lowest-cost option. Response rates were significantly lower using email (10%, p<0.01), the lowest-cost option. In contrast, among those aged 65+ years, mail was superior to the electronic methods (p<0.02).

The patient portal was among the most effective ways to reach research participants, and was less expensive than surveys administered by mail or telephone.

Research shows incentives can motivate faculty to increase their engagement in mentoring, despite a myriad of institutional barriers. One such incentive may be the implementation of a university-wide mentor award program to promote a culture of mentorship.

A new mentorship award was created at a research-intensive university and faculty recipients were surveyed to assess their perceptions of the award’s impact on their mentoring practices and career.

Sixty-two percent of awardees (n=21) completed the survey and felt the recognition incentivized them to engage in further mentoring and participate in formal mentorship training. Most awardees referenced the award in their CVs, performance evaluations, and grant proposals. Additionally, they felt the award effectively promoted mentoring among the broader faculty community.

Growth of clinical and translational research depends in part on the mentorship received by early career faculty. Therefore, other research universities may benefit from implementing such awards.