Training for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.

Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.

Forty-eight competency statements in 8 domains were developed.

Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

This paper reports on the baseline stage of a qualitative evaluation of the application of the Innovative Scorecard (ISC) to the Clinical and Translational Science Award (CTSA) at the University of Texas Medical Branch (UTMB) at Galveston. The ISC is adopted from the established Balanced Scorecard system for strategic planning and performance management. In formulating the evaluation, we focused on the organizational identity literature.

The initial evaluation consisted of a series of semi-structured interviews with 22 participants of the ISC Boot Camp conducted in July 2015.

The logic of grounded theory pointed to the clustering of perceptions of the ISC around respondents’ occupational locations at UTMB. Administrators anticipate the expansion of planning activities to include a wider range of participants under the current CTSA award period (2015–2020) than under our first CTSA approval period (2009–2014). A common viewpoint among the senior scientists was that the scientific value of their work will continue to speak for itself without requiring the language of business. Junior scientists looked forward to the ISC’s emphasis on increasingly horizontal leadership that will give them more access to and more control over their work and resources. Postdocs and senior staff welcomed increased involvement in the total research process at UTMB.

The report concludes with strategies for future follow-up.

Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of “incidental” findings, in easy-to-understand language.

After reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questions that she or he is encouraged to ask the investigator, and (2) a more detailed companion guide for investigators to help them develop simple-language answers to the questions. Both documents are available to use or modify.

We propose an approach to obtaining informed consent for NGS studies that encourages discussion of key issues without creating a complex, comprehensive document for participants; it also maximizes investigator flexibility. We also suggest mechanisms to return restricted information to participants.

We describe the effectiveness of community outreach and engagement in supporting recruitment for the US National Children’s Vanguard Study between 2009 and 2012.

Thirty-seven study locations used 1 of 4 strategies to recruit 18–49-year-old pregnant or trying to conceive women: (1) Initial Vanguard Study used household-based recruitment; (2) Direct Outreach emphasized self-referral; (3) Enhanced Household-Based Recruitment enhanced Initial Vanguard Study strategies; and (4) Provider-Based Recruitment recruited through healthcare providers. Outreach and engagement included advance letters, interactions with healthcare providers, participation in community events, contacts with community organizations, and media outreach.

After 1–2 years, 41%–74% of 9844 study-eligible women had heard about the National Children’s Vanguard Study when first approached. Women who heard were 1.5–3 times more likely to consent. Hearing via word-of-mouth or the media most frequently predicted consent. The more sources women heard from the higher the odds of consent.

We conclude that tailored outreach and engagement facilitate recruitment in cohort studies.

It is not clear how to effectively recruit healthy research volunteers.

We developed an electronic health record (EHR)-based algorithm to identify healthy subjects, who were randomly assigned to receive an invitation to join a research registry via the EHR’s patient portal, letters, or phone calls. A follow-up survey assessed contact preferences.

The EHR algorithm accurately identified 858 healthy subjects. Recruitment rates were low, but occurred more quickly via the EHR patient portal than letters or phone calls (2.7 vs. 19.3 or 10.4 d). Effort and costs per enrolled subject were lower for the EHR patient portal (3.0 vs. 17.3 or 13.6 h, $113 vs. $559 or $435). Most healthy subjects indicated a preference for contact via electronic methods.

Healthy subjects can be accurately identified from EHR data, and it is faster and more cost-effective to recruit healthy research volunteers using an EHR patient portal.

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.

This study describes the design, operation, and evaluation of a community-based research (CBR) consult service within the setting of a Clinical and Translational Science Award (CTSA) institution. To our knowledge, there are no published evaluations of a CBR consult service at a CTSA hub.

A CBR consult service was created to support faculty, health-care providers/research coordinators, trainees, community-based organizations, and community members. A framework was developed to assess the stages of client engagement and to foster clear articulation of client needs and challenges. A developmental evaluation system was integrated with the framework to track progress, store documents, continuously improve the consult service, and assess research outcomes.

This framework provides information on client numbers, types, services used, and successful outreach methods. Tracking progress reveals reasons that prevent clients from completing projects and facilitates learning outcomes relevant to clients and funding agencies. Clients benefit from the expert knowledge, community connections, and project guidance provided by the consult service team, increasing the likelihood of study completion and achieving research outcomes.

This study offers a framework by which CTSA institutions can expand their capacity to conduct and evaluate CBR while addressing challenges that inhibit community engagement.

Clinical and Translational Science Awards (CTSAs) and Practice-Based Research Networks (PBRNs) have complementary missions. We replicated a 2008 survey of CTSA-PBRN leaders to understand how organizational relationships have evolved.

We surveyed 60 CTSA community engagement (CE) Directors and 135 PBRN Directors and analyzed data using between and within-group comparisons.

In total, 43% of CTSA CE Directors (26/60) and 42% of PBRN Directors (57/135) responded. Quantitative responses revealed growing alignment between CTSA/PBRN perceptions, with a few areas of discordance. CE Directors noted declining financial support for PBRNs. PBRN Directors identified greater CTSA effectiveness in PBRN engagement, consultation, and collaborative grant submissions. Qualitative data revealed divergent experiences across CTSA/PBRN programs.

Relationships between CTSAs and PBRNs are maturing; for some that means strengthening and for others a growing vulnerability. Findings suggest a mutual opportunity for PBRNs and CTSAs around applied research. Studies to characterize exemplar CTSA-PBRN collaborations are needed.

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

The application of digital monitoring biomarkers in health, wellness and disease management is reviewed. Harnessing the near limitless capacity of these approaches in the managed healthcare continuum will benefit from a systems-based architecture which presents data quality, quantity, and ease of capture within a decision-making dashboard.

A framework was developed which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite, and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare.

The de novo framework implies consideration of physiological, behavioral, and environmental factors in the context of biomarker capture and analysis. Application in disease and wellness is highlighted, and incorporation in clinical feedback loops and closed-loop systems is illustrated.

The study of contextualized biomarkers has the potential to offer rich and insightful data for clinical decision making. Moreover, advancement of the field will benefit from innovation at the intersection of medicine, engineering, and science. Technological developments in this dynamic field will thus fuel its logical evolution guided by inputs from patients, physicians, healthcare providers, end-payors, actuarists, medical device manufacturers, and drug companies.

Computational analysis of genome or exome sequences may improve inherited disease diagnosis, but is costly and time-consuming.

We describe the use of iobio, a web-based tool suite for intuitive, real-time genome diagnostic analyses.

We used iobio to identify the disease-causing variant in a patient with early infantile epileptic encephalopathy with prior nondiagnostic genetic testing.

Iobio tools can be used by clinicians to rapidly identify disease-causing variants from genomic patient sequencing data.

We aimed to improve the research consenting process by developing and evaluating simplified consent forms.

Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.

At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (p<0.001).

Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

The Learning Health System Network clinical data research network includes academic medical centers, health-care systems, public health departments, and health plans, and is designed to facilitate outcomes research, pragmatic trials, comparative effectiveness research, and evaluation of population health interventions.

The Learning Health System Network is 1 of 13 clinical data research networks assembled to create, in partnership with 20 patient-powered research networks, a National Patient-Centered Clinical Research Network.

Herein, we describe the Learning Health System Network as an emerging resource for translational research, providing details on the governance and organizational structure of the network, the key milestones of the current funding period, and challenges and opportunities for collaborative science leveraging the network.

Science Cafés facilitated by the Clinical and Translational Science Institute of Southeast Wisconsin seek to increase health and scientific literacy through informal conversation between researchers and community members. The goal was to understand what factors have the greatest influence on attendees’ perceived changes in health and science literacy levels (PCHSL) to increase impact.

Previous research established the evaluation used in the Science Cafés to measure PCHSL. In this study, comparisons were made between (1) 2 different approaches to Science Cafés (Genomics Science Cafés or Health Science Cafés) and (2) regression models to show which factors best predicted PCHSL.

The approach of the Genomics Science Cafés series to Science Cafés showed a larger impact on PCHSL. Regression models suggest SES and education significantly contributes to PCHSL.

Insights for program development to have greater impact on PCHSL were identified. Continuing to optimize dissemination of research findings to the public is essential for improving community health and well-being.