Library-based Clinical and Translational Research Support Recommended Citation Library-based Clinical and Translational Research Support*

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 teambased 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 librarybased 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][6][7][8][9][10][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 respec-tive 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.

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]. Library support activities

Administration
The Administration KFC is composed of a lead administrator from each institution and provides direction for program execution by sharing best practices and methods, facilitating grants management, collaborating, and managing programs. This KFC also undertakes special projects for consortium leadership.
Assist with events such as retreats and seminar series; provide consultation and training services on library tools and services (searching bibliographic databases, utilizing bibliographic management software, etc.); create a translational science institute (TSI) collection in the campus institutional repository containing peer-reviewed journal articles and other materials; participate in planning retreats and goal development workgroups; assist administrative core with large-scale institutional grant proposals (conduct literature searches, organize and format references); provide consultation services for productivity and performance data sources; assist with facilitating current and retrospective compliance of public access mandates; advise administration of new trends or efforts in the field such as researcher identifiers (e.g., ORCID [66] Collaborate with conflict of interest (COI) officer and TSI research support staff to survey faculty perceptions of COI and identify training needs; assist research subject advocate to find information to support development of a training certificate program for clinical trial coordinators; support and develop training efforts related to human research subjects, COI, scholarly communications (e.g., responsible conduct of research, scholarly publication issues, public access mandates, copyright).

Clinical research management
The Clinical Research Management (CRM) KFC supports efforts to improve efficiency, reduce cost, and support research participant safety in areas such as protocol development; regulatory reviews including institutional review board (IRB) or institutional animal care and use committee (IACUC) review; study recruitment and retention; and data management tools, processes, and quality standards; among others.
Participate on the TSI's regulatory knowledge and research support committee (RKRS) and contribute to the development of standard operating procedures for investigative new drugs (INDs) and other RKRS research support activities; serve on committee that validates and creates validated survey instruments and questionnaires for researchers to use in their studies; support IRB, including assisting with protocols, performing or training researchers to perform searches related to IRB protocols, and integrating a librarian into the IRB; train in Clinicaltrials.gov compliance; provide customized literature search services. Clinical services core The Clinical Service Core (CSC) KFC shares best practices, resources, and business models on topics related to technological, nursing, and other expertise that may not be generally available in a clinic setting but that are required for translational science.
Participate on the TSI RKRS; develop resource guides (e.g., research participant confidentiality resources and policies); serve on a campus-wide dissemination and implementation workgroup; provide advice and training on topics related to enhancing the dissemination of research [19].

Communications
The Communications KFC includes CTSA and National Institutes of Health (NIH) staff who share local and national communications best practices, activities, and experiences; and identify communications opportunities and challenges. The Communications KFC works to increase awareness of program value, improve dissemination of National Center for Advancing Translational Sciences (NCATS) and CTSA-related news and information, and supports collaborations.
Provide consultations to enhance awareness of research efforts; collaborate with TSI on materials and messaging from the local institute to stakeholders on the website [20], in newsletters, and emails; facilitate social media activities (e.g., Twitter, blogs, Facebook) for efforts within the local institute [21]; support open access initiatives.  Provide instruction on team science activities, resources, and strategies; provide library services to support grant writing and clinical trial development.
* The fourteen CTSA key function areas are listed in the far left column, and the mission of the corresponding key function committee [4] within the CTSA structure is indicated in the middle column. Reported or potential library service activities that support key function areas are listed in the third column; activities listed include survey results [2,3], results of discussions and brainstorming activities from continuing education courses [12,13], personal communications, and services provided by the authors at their respective institutions.

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 othersoffering 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][40][41][42][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 interinstitutional 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 crossdisciplinary 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 informationistintegration 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][52][53][54]; health information management for quality improvement [55]; research impact [56]; bioinformatics and genomics [6,8,10,[57][58][59][60]; community outreach support; and team science [61].
Assessing library-based translational support services   [1] and become familiar with goals and key function areas of the consortium. Understand the program and the national infrastructure in place to facilitate this work. 2. Understand your institution's proposal and consider ways that the library can help meet the stated goals. 3. Understand national-level competencies [79]; how can the library help meet these competencies? 4. Rebrand or reorganize a library division to align with major initiatives or areas of emphasis on campus and consider renaming it so that this emphasis is clear to campus stakeholders [80]. 5. Reassign existing staff, provide training if necessary, and change working job title to indicate translational support. Encourage some specialization among existing staff; some areas to consider include research database searching, evaluation activities, community outreach, ontology support, and semantic web standards and technologies. Hire subject specialists such as statisticians or basic or social scientists to support specialized needs; build a service program around their expertise and forge new partnerships. 6. Send library staff to nonlibrary conferences and workshops for training on team-based science, informatics, or research networking systems. Some examples include the American Medical Informatics Association joint summits on translational informatics and the annual VIVO conference. 7. Be familiar with trends and policy issues and how they can be opportunities for the library (e.g., National Institutes of Health [NIH] public access policy and data sharing mandates). 8. Attend a variety of campus events, including seminars and classes from the translational science institute (TSI). 9. Seek out interdisciplinary collaborations and look for funding. This helps to validate the library's contribution and move the project and partnership forward. (See National Library of Medicine administrative supplements [81], for example.) 10. Focus target populations for library projects to those emphasized by the local TSI. 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.