A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.

BACKGROUND: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. MATERIALS AND METHODS: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25-30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service. RESULTS: Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days. CONCLUSION: National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.

Promoting interdisciplinary research to respond to public health crises: The response of the Columbia University CTSA to the opioid crisis.

Effectively addressing public health crises requires dynamic and nimble interdisciplinary collaborations across the translational spectrum, from bench to clinic to community. The Clinical and Translational Science Award (CTSA) Program hubs are uniquely suited to facilitate interdisciplinary collaborations across universities and academic medical centers. This paper describes the activities at the Columbia University CTSA Program hub to address a current public health crisis, the opioid epidemic. Columbia's CTSA Program hub led a three-phase approach, based on the Conceptual Model of Transdisciplinary Scientific Collaboration as described by Stokols et al.: (1) a university-wide planning and brainstorming phase to identify key leaders across many domains who are influential in addressing the opioid epidemic, (2) a campus-wide and community outreach to identify all interested parties, and (3) ongoing targeted support for collaboration development. Preliminary metrics of success are interdisciplinary collaborations and grant funding. We describe recent examples of how interdisciplinary collaboration, academic-community partnership, and pilot funding contributed to the development and funding of innovative interdisciplinary research, including the New York site of the HEALing Communities initiative. The processes are now being used to support interdisciplinary approaches for other translational public health issues.

Evaluation and the NIH clinical and translational science awards: a "top ten" list.

Since 2006, a total of 61 Clinical and Translational Science Institutes (CTSAs) have been funded by the National Institutes of Health (NIH), with the aim of reducing translation time from a bench discovery to when it impacts patients. This special issue of Evaluation & the Health Professions focuses on evaluation within and across the large, complex system of the CTSA Program of NIH. Through insights gained by reading the articles in this special edition and the experience of the authors, a "top ten" list of lessons learned and insights gained is presented. The list outlines issues that face those who evaluate the influence of the CTSA Program, as they work to anticipate what will be needed for continuing success. Themes include (1) considering the needs of stakeholders, (2) the perspective of the evaluators, (3) the importance of service improvement, (4) the importance of teams and people, (5) costs and return on investments, (6) methodology considerations to evaluate the CTSA enterprise, (7) innovation in evaluation, (8) defining the transformation of research, (9) evaluating the long-term impact of the CTSAs on public health, and (10) contributing to science policy formulation and implementation. The establishment of the CTSA Program, with its mandated evaluation component, has not only influenced the infrastructure and nature of translational research but will continue to impact policy and management in science.

Mentor training within academic health centers with Clinical and Translational Science Awards.

Multiple studies highlight the benefits of effective mentoring in academic medicine. Thus, we sought to quantify and characterize the mentoring practices at academic health centers (AHCs) with Clinical and Translational Science Awards (CTSA). Here we report findings pertaining specifically to mentor training at the level of the KL2 mentored award program, and at the broader institutional level. We found only four AHCs did not provide any form of training. One-time orientation was most prevalent at the KL2 level, whereas formal face-to-face training was most prevalent at the institutional level. Despite differences in format usage, there was general consensus at both the KL2 and institutional level about the topics of focus of face-to-face training sessions. Lower-resource training formats utilized at the KL2 level may reveal a preference for preselection of qualified mentors, while institutional selection of resource-heavy formats may be an attempt to raise the mentoring qualifications of the academic community as a whole. The present work fits into the expanding landscape of academic mentoring literature and sets the framework for future longitudinal, outcome studies focused on identifying the most efficient strategies to develop effective mentors.

The Mentoring Competency Assessment: validation of a new instrument to evaluate skills of research mentors.

PURPOSE: To determine the psychometric properties of the Mentoring Competency Assessment (MCA), a 26-item skills inventory that enables research mentors and mentees to evaluate six competencies of mentors: maintaining effective communication, aligning expectations, assessing understanding, addressing diversity, fostering independence, and promoting professional development. METHOD: In 2010, investigators administered the MCA to 283 mentor-mentee pairs from 16 universities participating in a trial of a mentoring curriculum for clinical and translational research mentors. The authors analyzed baseline MCA data to describe the instrument's psychometric properties. RESULTS: Coefficient alpha scores for the MCA showed reliability (internal consistency). The hypothesized model with its six latent constructs (competencies) resulted in an acceptable fit to the data. For the instrument completed by mentors, chi-square = 663.20; df = 284; P < .001; root mean square error of approximation (RMSEA) = 0.069 (90% CI, 0.062-0.076); comparative fit index (CFI) = 0.85; and Tucker-Lewis index (TLI) = 0.83. For the instrument completed by mentees, chi-square = 840.62; df = 284; P < .001; RMSEA = 0.080 (90% CI, 0.063-0.077); CFI = 0.87; and TLI = 0.85. The correlations among the six competencies were high: 0.49-0.87 for mentors, 0.58-0.92 for mentees. All parameter estimates for the individual items were significant; standardized factor loadings ranged from 0.32 to 0.81 for mentors and 0.56 to 0.86 for mentees. CONCLUSIONS: The findings demonstrate that the MCA has reliability and validity. In addition, this study provides preliminary norms derived from a national sample of mentors and mentees.

Developing a computer touch-screen interactive colorectal screening decision aid for a low-literacy African American population: lessons learned.

African Americans have higher colorectal cancer (CRC) mortality than White Americans and yet have lower rates of CRC screening. Increased screening aids in early detection and higher survival rates. Coupled with low literacy rates, the burden of CRC morbidity and mortality is exacerbated in this population, making it important to develop culturally and literacy appropriate aids to help low-literacy African Americans make informed decisions about CRC screening. This article outlines the development of a low-literacy computer touch-screen colonoscopy decision aid using an innovative marketing method called perceptual mapping and message vector modeling. This method was used to mathematically model key messages for the decision aid, which were then used to modify an existing CRC screening tutorial with different messages. The final tutorial was delivered through computer touch-screen technology to increase access and ease of use for participants. Testing showed users were not only more comfortable with the touch-screen technology but were also significantly more willing to have a colonoscopy compared with a "usual care group." Results confirm the importance of including participants in planning and that the use of these innovative mapping and message design methods can lead to significant CRC screening attitude change.

Policies, activities, and structures supporting research mentoring: a national survey of academic health centers with clinical and translational science awards.

PURPOSE: To document the frequency of policies and activities in support of mentoring practices at institutions receiving a U.S. National Institutes of Health's Clinical and Translational Science Award (CTSA). METHOD: The study consisted of a 69-item survey with questions about the inclusion (formal or informal) of policies, activities, and structures supporting mentoring within CTSA-sponsored research (i.e., KL2 programs) and, more broadly, in the CTSA's home institution. The survey, conducted from November 2010 through January 2011, was sent to the 55 institutions awarded CTSAs at the time of the survey. Follow-up phone interviews were conducted to clarify responses as needed. RESULTS: Fifty-one of 55 (92%) institutions completed the survey for institutional programs and 53 of 55 (96%) for KL2 programs. Responses regarding policies and activities involving mentor criteria, mentor-mentee relationship, incentives, and evaluative mechanisms revealed considerable variability between KL2 and institutional programs in some areas, such as having mentor qualification criteria and processes to evaluate mentors. The survey also identified areas, such as training and women and minority mentoring programs, where there was frequent sharing of activities between the institutional and KL2 programs. CONCLUSIONS: KL2 programs and institutional programs tend to have different preferences for policies versus activities to optimize qualification of mentors, the mentor-mentee relationship, incentives, and evaluation mechanisms. Frequently, these elements are informal. Individuals in charge of implementing and maintaining mentoring initiatives can use the results of the study to consider their current mentoring policies, structures, and activities by comparing them with national patterns within CTSA institutions.

Mentorship in the context of interdisciplinary geriatric research: lessons learned from the RAND/Hartford Program for Building Interdisciplinary Geriatric Research Centers.

In light of the growing trend toward formalized research mentorship for effectively transmitting the values, standards, and practices of science from one generation of researchers to the next, this article provides the results of an exploratory study. It reports on research mentorship in the context of interdisciplinary geriatric research based on experiences with the RAND/Hartford Program for Building Interdisciplinary Geriatric Research Centers. At the end of the 2-year funding period, staff from the RAND Coordinating Center conducted 60- to 90-minute open-ended telephone interviews with the co-directors of the seven centers. Questions focused on interdisciplinary mentorship activities, barriers to implementing these activities, and strategies for overcoming them, as well as a self-assessment tool with regard to programs, policies, and structures across five domains, developed to encourage research mentorship. In addition, the mentees at the centers were surveyed to assess their experiences with interdisciplinary mentoring and the center. According to the interviewees, some barriers to successful interdisciplinary mentoring included the mentor's lack of time, structural support, and the lack of a clear definition of interdisciplinary research. Most centers had formal policies in place for mentor identification and limited policies on mentor incentives. Mentees uniformly reported their relationships with their mentors as positive. More than 50% of mentees reported having a primary mentor from within their discipline and had more contact with their primary mentor than their secondary mentors. Further research is needed to understand the complexity of institutional levers that emerging programs might employ to encourage and support research mentorship.

Deriving competencies for mentors of clinical and translational scholars.

Although the importance of research mentorship has been well established, the role of mentors of junior clinical and translational science investigators is not clearly defined. The authors attempt to derive a list of actionable competencies for mentors from a series of complementary methods. We examined focus groups, the literature, competencies derived for clinical and translational scholars, mentor training curricula, mentor evaluation forms and finally conducted an expert panel process in order to compose this list. These efforts resulted in a set of competencies that include generic competencies expected of all mentors, competencies specific to scientists, and competencies that are clinical and translational research specific. They are divided into six thematic areas: (1) Communication and managing the relationship, (2) Psychosocial support, (3) Career and professional development, (4) Professional enculturation and scientific integrity, (5) Research development, and (6) Clinical and translational investigator development. For each thematic area, we have listed associated competencies, 19 in total. For each competency, we list examples that are actionable and measurable. Although a comprehensive approach was used to derive this list of competencies, further work will be required to parse out how to apply and adapt them, as well future research directions and evaluation processes.