Academic health systems and their investigators are challenged to systematically assure clinical research regulatory compliance. This challenge is heightened in the emerging era of centralized single Institutional Review Boards for multicenter studies, which rely on monitoring programs at each participating site.

To describe the development, implementation, and outcome measurement of an institution-wide paired training curriculum and internal monitoring program for clinical research regulatory compliance.

Standard operating procedures (SOPs) were developed to facilitate investigator and research professional adherence to institutional policies, federal guidelines, and international standards. An SOP training curriculum was developed and implemented institution-wide. An internal monitoring program was launched, utilizing risk-based monitoring plans of pre-specified frequency and intensity, assessed upon Institutional Review Boards approval of each prospective study. Monitoring plans were executed according to an additional SOP on internal monitoring, with monitoring findings captured in a REDCap database.

We observed few major violations across 3 key domains of clinical research conduct and demonstrated a meaningful decrease in the rates of nonmajor violations in each, over the course of 2 years.

The paired training curriculum and monitoring program is a successful institution-wide clinical research regulatory compliance model that will continue to be refined.

Senior Instructors and Assistant Professors in their first academic appointment may not have all the tools for an efficient start to their careers. Although many institutions provide access to mentoring programs and seminars on faculty development, the timing and format of the offerings often conflict with ongoing responsibilities of the faculty, particularly clinical faculty.

We established a collaboration between the Clinical and Translational Science Institute (CTSI) and the University of Rochester Medical Center Office for Faculty Development with the goal of developing a week-long Junior Faculty Core Curriculum that would better suit faculty schedules. We convened focus groups and with their help, identified themes for inclusion in the course. Speakers were identified from among local senior faculty. University leadership was enlisted in promoting the course. Individual speakers and course content were evaluated daily, at the end of the week-long course, and 6 months later. Planning for subsequent years incorporated the feedback. Yearly evaluations and subsequent course modification continued.

Junior faculty from nearly every department in the Medical Center were represented. There was high learner satisfaction and participation however several limitations were identified and addressed in subsequent years. The focus on principles and available resources, not specific skills or content was appropriate. Daily interactions among participants from a wide variety of departments fostered networking among faculty who may not otherwise have met and discussed common interests

The ultimate value of such an early, intensive faculty development program will depend on whether it equips junior faculty to organize, develop, and achieve their academic goals better than alternative formats. This will require further study.

Nurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.

A collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.

A pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.

As the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

General life stress has been associated with altered DNA methylation in individuals of African Ancestry, although the relationship between parenting stress and DNA methylation has not been described. The purpose of this study was to examine the relationship between maternal parenting stress and DNA methylation among African Ancestry mother-child dyads.

We evaluated epigenome-wide DNA methylation relative to parenting stress in 74 mother-child dyads using linear mixed models.

Significant variation in maternal DNA methylation at 95 CpG sites was associated with level of parenting stress. Notably, we identified a change in DNA methylation associated with poly (ADP-ribose) polymerase-1, which plays a key role in stress signaling. We did not identify any significant variation in child DNA methylation related to maternal parenting stress.

However, DNA methylation patterns observed in children mirrored patterns observed in their mothers. The results suggest that differential maternal DNA methylation is associated with higher levels of parenting stress.

It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from ‘fundamental’ (necessary for all) to ‘specialized’ (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized.

We surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by ‘fundamental’ and ‘specialized.’

There were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one’s own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%).

We have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.

A core challenge of a multidisciplinary and multi-organizational translational research enterprise such as a Clinical and Translational Research Award (CTSA) is coordinating and integrating the work of individuals, workgroups, and organizations accustomed to working independently and autonomously. Tufts Clinical and Translational Science Institute (CTSI) undertook and studied a multifacted intervention to address this challenge and to create a culture of systems thinking, process awareness, responsive to others' needs, and shared decision-making.

The intervention, based on relational coordination, included 1) relational interventions, in three staff retreats and a diagnostic survey to provide feedback on the current quality of relational coordination, and 2) structural interventions, in the launching of five new cross-functional teams with regular meeting structures.

A mixed-methods evaluation yielded quantitative data via two types of team surveys and qualitative data via interviews and meeting observations.

The findings suggest that interventions to improve relational coordination are feasible for CTSAs, including good fidelity to the model and staff/physician engagement. Survey and interview data suggest model improvements in coordination and alignment. Further research about their optimal design is warranted.

The National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is unnecessary, values knowledge over competency, may be counter-productive, and is unlikely to achieve any worthwhile outcome. We lay out these arguments in the hope of stimulating a robust discussion among leaders, faculty, and learners engaged in clinical research education and training.

This paper is the fourth in a 5-part series that focuses on educating and training the clinical and translational science workforce. The goal of this paper is to delineate components of effective career development programs that go beyond didactic training. All academic health centers with a Clinical and Translational Science Award have a KL2 career development award for junior faculty, and many also have a TL1 training program for predoctoral and postdoctoral fellows. The training across these programs varies, however junior investigators across the United States experience similar challenges. Junior investigators can get overwhelmed with the demands of building their own research program, particularly in academia. 1Often, they are sidetracked by competing demands that can derail their progress. In these situations, junior investigators experience frustration and may search for alternative career paths. By providing them with additional professional skills in the 5 domains of: (1) self-awareness; (2) selecting the right topic and securing funding; (3) getting adequate support; (4) working with others; and (5) managing yourself, your career, and your demands. We will give junior investigators additional tools to manage these demands and facilitate their own career success.

The Institute of Medicine recommended the advance of innovation and entrepreneurship training programs within the Clinical & Translational Science Award (CTSA) program; however, there remains a gap in adoption by CTSA institutes. The University of Michigan’s Michigan Institute for Clinical & Health Research and Fast Forward Medical Innovation (FFMI) partnered to develop a pilot program designed to teach CTSA hubs how to implement innovation and entrepreneurship programs at their home institutions.

The program provided a 2-day onsite training experience combined with observation of an ongoing course focused on providing biomedical innovation, commercialization and entrepreneurial training to a medical academician audience (FFMI fastPACE).

All 9 participating CTSA institutes reported a greater connection to biomedical research commercialization resources. Six launched their own version of the FFMI fastPACE course or modified existing programs. Two reported greater collaboration with their technology transfer offices.

The FFMI fastPACE course and training program may be suitable for CTSA hubs looking to enhance innovation and entrepreneurship within their institutions and across their innovation ecosystems.

Research coordinators (RCs) are vital to the clinical research enterprise, ensuring research is conducted ethically, results are scientifically sound and human research subjects are protected. Given the absence of a prior systematic inquiry, we sought to understand the ways in which Clinical & Translational Science Award-funded academic health centers support RCs.

Our survey asked questions about existing coordinator networks and where none existed, collected data on the characterization of resources and services provided to support RCs (outside of salary).

Findings show 4 mechanisms support RCs: identification of the workforce, professionalization of the position, dissemination of information, and offering of services.

An academic health center that wishes to deliver research training and services to their RC workforce will need identification and communication structures in place before supportive activities can be effectively implemented.

Efforts to address health disparities and achieve health equity are critically dependent on the development of a diverse research workforce. However, many researchers from underrepresented backgrounds face challenges in advancing their careers, securing independent funding, and finding the mentorship needed to expand their research.

Faculty from the University of Maryland at College Park and the University of Wisconsin-Madison developed and evaluated an intensive week-long research and career-development institute—the Health Equity Leadership Institute (HELI)—with the goal of increasing the number of underrepresented scholars who can sustain their ongoing commitment to health equity research.

In 2010-2016, HELI brought 145 diverse scholars (78% from an underrepresented background; 81% female) together to engage with each other and learn from supportive faculty. Overall, scholar feedback was highly positive on all survey items, with average agreement ratings of 4.45-4.84 based on a 5-point Likert scale. Eighty-five percent of scholars remain in academic positions. In the first three cohorts, 73% of HELI participants have been promoted and 23% have secured independent federal funding.

HELI includes an evidence-based curriculum to develop a diverse workforce for health equity research. For those institutions interested in implementing such an institute to develop and support underrepresented early stage investigators, a resource toolbox is provided.

Previous studies have examined the impact of Clinical and Translational Science Awards programs on other outcomes, but not on grant seeking. The authors examined the effects on grant seeking of the Michigan Institute for Clinical & Health Research (MICHR), a Clinical and Translational Science Awards institute at the University of Michigan.

We assessed over 63,000 grant proposals submitted at the University of Michigan in the years 2002–2012 using data from the university and MICHR’s Tracking Metrics and Reporting System. We used a retrospective, observational study of the dynamics of grant-seeking success and award funding. Heckman selection models were run to assess MICHR’s relationship with a proposal’s success (selection), and subsequently the award’s size (outcome). Models were run for all proposals and for clinical and translational research (CTR) proposals alone. Other covariates included proposal classification, type of grant award, academic unit, and year.

MICHR had a positive and statistically significant relationship with success for both proposal types. For all grants, MICHR was associated with a 29.6% increase in award size. For CTR grants, MICHR had a statistically nonsignificant relationship with award size.

MICHR’s infrastructure, created to enable and enhance CTR, has also created positive spillovers for a broader spectrum of research and grant seeking.