Library-based clinical and translational research support

BACKGROUND

There has been a shift in the workflow at academic biomedical research and clinical care centers to promote more efficient clinical and community implementation of bench discoveries. Strong financial support for this effort is provided by the Clinical and Translational Science Awards (CTSAs) from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), awarded to about sixty biomedical research institutions constituting the CTSA Consortium 1. CTSAs offer an opportunity to speed the translation of bench discoveries to improved human health by transforming the research enterprise at the local, regional, and national levels. These efforts include large-scale infrastructure projects, institution-wide coordination and provision of services, incentives to facilitate collaboration and team-based science, and education programs designed to train the next generation of researchers.

In this age of translational science, biomedical libraries can provide critical support. In 2011, Tennant 2, 3 performed a survey to explore how libraries provided support to clinical and translational science researchers at CTSA-funded translational science institutes (TSIs). The majority of respondents indicated that they provided services to such researchers, and almost a third were officially affiliated with their institution's TSIs. Library-based translational research support programs are frequently built with a combination of specialized informationists (SIs), who often have advanced training in basic science or clinical areas, and librarians (Ls). By developing innovative services and providing access to a wide variety of information types and resources, libraries are in a key position to successfully respond to translational scientists' information needs.

This paper describes current and potential library-based support efforts for clinical and translational research and puts these activities into the context of key function areas (KFAs), following the national-level organizational scheme of the CTSA Key Function Committees 4 to support the goals of translational science.

ENVIRONMENTAL SCAN

The library-based TSI support activities reported in this paper were obtained through an environmental scan consisting of personal experiences, a literature search, an Internet review of conference presentations 3, 5–11, results of brainstorming activities conducted at continuing education (CE) courses 12, 13, and services provided by the authors at their respective institutions. The literature search was carried out in January 2013 to identify examples of service activities that was presented in tables and text and was not considered to be a comprehensive review. Searching was conducted using MEDLINE/PubMed, Web of Science, and SciVal Scopus databases. In addition, Google was used to locate additional conference abstracts and other gray literature. These searches included KFA-associated concepts and other related terms. Instructors of the cited Medical Library Association (MLA) CE classes contributed examples of library-based service concepts from class discussions that might align with the KFAs. Finally, the experiences of the authors, in terms of services either provided or envisioned for their institutions, were included. The authors' individual contributions to this report reflect their diverse environments: public and private institutions with different reporting structures (in the health sciences or the university library system) and levels of involvement with their respective TSIs. The examples gathered from these various sources were then organized into KFAs.

CTSA Consortium–level activities are focused on five strategic goals facilitated across fourteen KFAs by specific committees 4. The fourteen KFAs encompass a number of activities that are actively supported by libraries (e.g., research, clinical care, community outreach, and education). By considering the role of the library in the context of the fourteen KFAs, it was possible to identify existing and proposed service areas and understand how current services can be effectively presented to campus stakeholders. Table 1 presents the results of the scan. References denote published sources; other examples were derived as described above.

Table 1.

Current and potential library-based support efforts for clinical and translational research^*

KEY FINDINGS BY FUNCTION AREA

Administration

Library support of TSI administrative efforts is a natural fit and helps guide the work of the library in supporting other translational initiatives. Working directly with administrators facilitates library understanding of TSI priorities and positioning to respond to these needs in an efficient manner, enhancing the visibility of the library as a partner to support other TSI activities. While the majority of these efforts tend to play to traditional library strengths (e.g., literature searching, use of bibliographic resources, and reference management software), new opportunities arise in which libraries act as direct collaborators in strategic institute-level events. Additionally, libraries can inform administrators of trends and prospects in translational research and scholarly communications 14.

Biostatistics/epidemiology/research design (BERD)

Library-based support activities for biostatistics/epidemiology/research design (BERD) vary widely and can present libraries with a clear path toward more in-depth SI services, as BERD impacts TSIs on many levels, including research design and awareness and training on data sources and software. While a number of libraries have subject matter experts on staff to provide in-depth consultations and training, other libraries find that they can also offer support through coordinating software site licenses and organizing training opportunities from vendors or local topic experts 15, 16.

Clinical research ethics

Many libraries actively support the clinical research ethics KFA through collaborative partnerships and support services and gathering of resources for training programs. Libraries also work with research subject advocates to teach investigators and clinicians about scholarly publishing issues and developing curricula on the responsible conduct of research 17, 18.

Clinical research management

Facilitating the management and processes of clinical research is a key goal for a TSI. Each institution approaches this goal uniquely, but enhancing and formalizing communication among the intra-institutional clinical research support or regulation services is a common approach for library integration. While the names and structures differ across TSI sites, most contain an administrative coordinating group that serves as the connection point for units such as institutional review boards (IRBs), research offices, research support advocacy, clinical research centers, and technology transfer offices.

Clinical services core

The clinical services core KFA works to improve the efficiency of clinical research units (CRUs). To date, SIs and Ls have reported little or no involvement in these units, except for providing basic literature searching and standard library services to the staff. It is the opinion of the authors that opportunities to develop closer relationships with CRUs are most likely to develop from SI integration into the broader efforts of the TSI, such as service on their institutions' research support coordinating committee or through dissemination and impact work 19.

Communications

Communication about local and consortium-level activities is a vital component to the success of the overall CTSA program, and dissemination of research products and knowledge to stakeholders is critical. Communication activities and modes of dissemination represent an area where the library can leverage its campus relationships, understanding of the scholarly ecosystem, and expertise in targeted use of social media (e.g., wikis, dashboards, and research networking systems [RNS]) to help communicate the efforts of the TSI 20, 21 and facilitate communication and collaboration, thereby strengthening the cohesiveness of the national CTSA Consortium 22.

Community engagement

Community engagement in TSIs is of paramount importance because translational science cannot yield health outcomes that matter unless health disparities are addressed 23. Many SIs and Ls have been actively engaged in outreach programs, understanding health literacy and the importance of including underserved populations in the design, and implementation of health information and services 24, 25.

Comparative effectiveness research

Libraries are poised to provide information, guidance, and training on resources that can support comparative effectiveness research (CER) competencies 26 and inform CER efforts such as clinical trials or research project databases. The National Library of Medicine has developed excellent resources to support CER activities 27, providing a good starting point for libraries offering much-needed support to researchers working to understand how and why one intervention works better than another 28.

Education and career development

Education of the next generation of clinician-scientists is a major priority for the CTSA Consortium 29 and for institutions. There have been significant efforts at all levels to provide education and training for a multitude of topics related to research, clinical care, career development, team science, and others—offering the library the opportunity to support these activities.

Evaluation

Evaluation of scholarly output and assessment of research impact—particularly meaningful health outcomes resulting from translational research—is a growing trend and is important across all strategic goals of the consortium. Evaluation of biomedical research is typically conducted by traditional bibliometric measures and leverages skill sets that are well suited to the librarian. Some libraries extend evaluation by also using non-publication data, offering the opportunity for powerful analyses to demonstrate a more robust overview of the impact of research 30.

Informatics

Bioinformatics support services have been entrenched within libraries for almost twenty years 31. These services largely focus on training and database or tool support for researchers but more recently have morphed into broad support across bioinformatics, medical informatics, clinical informatics, and information technology (IT) infrastructures. Other activities include support of the RNS either by offering the tool directly through the library or by providing guidance on data sources or training to help facilitate local adoption and promote profile completeness. The authors find that support in this area often involves working with semantic web standards and technologies 32, offering another area where SI expertise may be applied.

Public-private partnerships

The CTSA Consortium institutions are encouraged to foster partnerships with each other, as well as with industry and other government-funded programs 33. Advancing public-private collaborations involves challenges and barriers 34, including intellectual property issues, proprietary challenges, communications, clinical trial recruitment, and other sensitive issues that require openness and transparency. SIs and Ls can best support partnerships through familiarity with the resources that TSIs leverage to identify possible partnerships and foster these relationships 35, 36.

Regulatory knowledge

Many libraries have adopted formal support programs in partnership with university administrative units to support NIH-funded authors on issues related to compliance with public access mandates or compliance with federal research regulations such as clinical trial registration, data entry into ClinicalTrials.gov, and responsible conduct of research. Formal training in responsible conduct of research practices is required by some funding agencies such as the National Science Foundation 37 and NIH 38, and such support demonstrates how libraries are evolving to address the complexity of research in the twenty-first century 39–43.

Translational

Ultimately, the library's expertise as a campus conduit, helping researchers and administrators find resources and collaborators, is a key way to serve the translational KFA whose goal is facilitating inter-institutional collaborations. Furthermore, libraries have a long history of helping researchers find resources and expertise by searching bibliographic databases 44, and adopting institutional RNS and associated data standards 31 to ensure richly structured data provides new opportunities for libraries to leverage their expertise in information management. Institutional repositories also serve to highlight research outputs that demonstrate cross-disciplinary and collaborative authorship patterns in translational science research 45.

DISCUSSION

Until recently, library support for clinical and translational research has generally included only basic reference and instructional services; however, more specialized services continue to develop, expanding the concept of the “informationist” 46. In 2008, the NIH Library reported expanded informationist-integration activities—many of which align with KFAs—including attending clinical rounds; providing protocol searching; providing data support services; providing critical appraisal of the literature; searching chemical, patent, and competitive intelligence; partnering in manuscript writing and coauthoring; and providing onsite training 47. Informationist collaboration with translational science researchers across the country has flourished in these areas and is expanding into new spheres, including integration of library, biomedical informatics, and scholarly communications into official TSI course work 8, 14; knowledge management 48; support for e-science 49; data curation 50; research networking 51–54; health information management for quality improvement 55; research impact 56; bioinformatics and genomics 6, 8, 10, 57–60; community outreach support; and team science 61.

Assessing library-based translational support services

To date, there has been no formal analysis of library-based support of TSIs, although this is essential to help libraries develop effective and efficient services. Evaluation research protocols should be codeveloped with new and expanding services. Indicators can provide anecdotal evidence that library-based support programs are succeeding. Perhaps the most obvious is the integration of library personnel into the TSI 62. Invitations to participate in TSI events, workgroups, and renewal efforts exemplify integration and provide evidence of deep TSI partnerships. Some SIs and Ls serve as official members of local KFA teams with their local TSIs, opening the door for participation on national CTSA-level KFCs and interest groups 63, 64 and assignment to CTSA-related projects such as the Research Electronic Data Capture (REDCap) Shared Digital Instrument Library Committee (REDLOC) 65. Perhaps the most significant indicator of success of a library-based program is financial support, through paid effort on the CTSA, commitment of funds for shared resources, and/or funds for library personnel to travel to conferences and training.

Moving forward with library-based translational science institute (TSI) services

Various barriers can make it difficult for libraries to successfully deliver services and resources to the local TSI. It can be difficult to understand what opportunities allow libraries to move forward in this arena and how the roles of library-based personnel are changing. Other significant barriers have confronted libraries for years, including a lack of understanding of library services and personnel by campus communities, and budget constraints to fund equipment, specialized tools, subscriptions or licenses, databases, and staff. Specialized service areas require expertise that does not always exist in the library. Inadequate training of existing library staff or a budget that does not allow new hires in specialty areas can present significant challenges when trying to develop support services for a TSI. The paucity of peer-reviewed manuscripts on the topic of libraries and TSI support, combined with an increasing number of conference reports on the topic, suggests to the authors that libraries engaged in TSI efforts should consider reporting their work in the peer-reviewed literature for the benefit of all.

Perhaps the biggest barrier for libraries is a lack of understanding of TSI goals and requirements, including national-level priority areas. Table 2 lists ways that libraries can gain such understanding. It is essential for libraries to be agile and creative in their TSI support efforts and outreach strategies. As libraries become better integrated across key areas, they become better poised to bridge silos and support the research, clinical, and community-based efforts of the TSI, ultimately ensuring a vibrant future for the library as a key partner in significant institutional efforts.

Table 2.

10 strategies for building a successful clinical and translational science support program

Table 1.

Continued