The primary goal of the Integrative Health Sciences Facility Core is to enable progressive translational, clinical, and population-based research projects that address environmental health concerns in our region. This will be archived through specific tactics, including:
- Provide support for collaborative and team-driven efforts among basic scientists, clinical researchers, community engagement experts, and public health researchers. In partnership with the above centers, we will provide services, instrumentation, technologies, and opportunities for cross-communication that foster integration of basic science, public health research including epidemiology and intervention studies, and patient-oriented clinical research.
- Provide and manage resources to facilitate the progression of EHS from basic mechanistic and toxicological research to more immediate translational programs that will impact our affected communities by improving public health and/or clinical practice.
- Facilitate ‘reverse-translational’ research activities by addressing community concerns or community-level study findings and developing programs to stimulate preclinical research activities at our institution. Using resources such as isolated cell culture studies and relevant animal model systems, we will facilitate research into the mechanisms underlying community environmental health issues.
The IHSFC serves as the primary institutional access point to specifically facilitate EHS-related translational and clinical studies. This facilitation will include moving studies forward from basic science to clinical science and/or population science studies, and will emphasize reverse efforts to develop cellular and animal studies to support and serve clinical and community observations and concerns.
Establishing a multi-directional alignment, the IHSFC will work in conjunction with the COEC to help bridge the gap between researchers and affected communities by working with the four Research Interest Groups. The UK CARES pilot project program will link core resources to new and evolving studies. The UK CARES analytical core draws on expertise in analytical chemistry, mass spectrometry, and biostatistics for quantitation of relevant analytes in complex biological and environmental samples.
The IHSFC is structured as both a central portal for investigators across the spectrum of research and a bridge to services within UK CARES and elsewhere in order remove barriers. In addition, to build on fresh perspectives that are emerging in any given area and to capitalize on promising strategies that may address critical barriers to progress, the IHSFC will work directly with investigators from the four Research Interest Groups (Cardiopulmonary Diseases, Metabolic Disorders, Cancer, and Child Health and Early Life Exposures) to identify projects with strong potential for translation, identify researchers with different types of expertise but complementary potential, and assist in making connections among them.
The IHSFC will play an active role in continuing development of these transdisciplinary research teams as they refine a novel concept and the research direction evolves. At that stage, the IHSFC and individual research team will work together to determine the nature of services required and employ a body of highly skilled facilitators who serve as first line coordinators of service access and delivery.
This core will have extensive interactions and linkages to other elements of the P30. For example, the IHSFC will facilitate frequent interactions with the Research Interest Groups, wherein teams or individual investigators will be encouraged and assisted in developing projects in targeted areas. IHSFC will also be linked to and serve the COEC, and will provide logistical and operational support for project ideas and concepts that are derived from the community engagement efforts of Dr. Ellen Hahn, COEC Leader, and her COEC Leadership Team.
Furthermore, the projects that are facilitated via the IHSFC staff will be typically linked to the analytical core, for support in biostatistics (study planning and/or statistical data analyses), and for analytical assay utilizations as requested. The pilot project program will also be involved as partners with the IHSFC mission since the funded pilot projects will be directed to access key services and tasks for project completion via study support mechanisms in the IHSFC.
The IHSFC benefits from several key available resources on our campus that facilitate research. These include the NIH funded CCTS, the UK Superfund, the Human Studies IRB, the Institutional Animal Care and Use Committee (IACUC), and the NCI-designated MCC. Rather than replicating the established abilities of these other sites, the IHSFC will complement their functions with specific efforts to promote EHS studies in humans via targeted assistance to minimize the barriers for projects to proceed.
It is important to clarify that the IHSFC has the primary mission to catalyze EHS translational and clinical studies, and that no entity on our campus currently serves this important mission. Furthermore, we realize that to have maximum impact, the IHSFC will need to coordinate its efforts and leverage the presence of these other entities to achieve its goals. In many cases, the IHSFC will access (e.g. purchase) key services that are in place via these other programs as appropriate. Drs. Bauer and Arnold and the IHSFC Oversight and Utilization Committee members all have excellent working relationships with these other campus resources, and therefore we are confident that the IHSFC will serve an important and unique function in our University of Kentucky research community.
Below are descriptions of services and expertise that the IHSFC will make available to UK CARES investigators. Key personnel that will participate in delivering these services as facilitators and are also shown where appropriate. See budget descriptions for details regarding funding strategies. Note that the IHSFC will provide bidirectional project support. It is expected that there will be cases where basic scientists will want to extend investigations to human trials, and is also expected to have human studies, or COEC identified research questions, to stimulate non-human studies. The IHSFC will enable and enhance both of these arenas by providing access to personnel and related resources to minimize the barriers for success.
Human Studies Facilitation and Support: IHSFC will provide turnkey services to minimize the barriers for EHS investigators to develop pilot human research studies. For projects involving human studies the IHSFC has three defined elements of project development and management:
- Study development and performance,
- Specimen management, and
- Human data archive.
Each of these elements has individuals with already established expertise specific for that element of project progress who will serve as facilitators. These individuals will serve as initial point of contact for elements of project progress; in some cases they will perform the specific tasks themselves, in other cases they will facilitate interactions with other entities to deliver the service/skill required.
Descriptions of project-related tasks and facilitator responsibilities are provided here: Study Development and Performance – The IHSFC will provide assistance in study development, determination and guidance with respect to feasibility and logistics, assistance in regulatory aspects (IRB submission and approvals, etc.), and connection to community settings where appropriate. Specimen Management – The human studies supported by the IHSFC will typically involve collection and management of specimens including environmental samples and/or biological materials from enrolled subjects. Studies supported will include prospective and newly developed methods for new sample collections, and other studies of new measurements/analyses for already banked samples. Thus, a strategy to manage diverse sample types, storage needs, and project needs is required. As of March 2015 there are at least seven currently active large-scale bio-banking efforts on the UK campus, with a wide range of sample types (e.g. blood, serum, saliva, tumor specimens, other solid tissues, etc.). The nature of individual projects typically defines the best strategies for sample collection, replicate aliquots, storage, and labeling. The IHSFC will have access to these diverse sites and strategies already available across campus, and will also have access to its own capacity for program specific sample management (via Dr. Bauer’s research labs and personnel). The IHSFC has established links with several sample archiving systems on campus, and each project will be evaluated to determine which setting is most appropriate for sample collection and storage. The key aspect of the IHSFC is to facilitate pilot projects, and generate preliminary data and project organization to catalyze extramural projects; prudent planning and scalability are therefore important issues that we will evaluate for each project proposed. Human Data Archive – The IHSFC will support prospective efforts in collection of human data, and will also facilitate access to already existing human data sets that P30 investigators have made available for additional study developments. Non-Human EHS Study Support (‘reverse-translation’) – This aspect of the IHSFC will facilitate ‘translation’ of community and/or public health concerns or observations to rationally designed and conducted preclinical research using cell culture or animal model approaches. Our current EHS research community has a collective strength in basic research studies, and we will rely on this collective expertise to assist research interest groups and individual PIs to address real world health concerns from our community.
John Bauer, PhD
Wayne Sanderson, PhD
Susanne Arnold, MD
John D’Orazio, MD
Kevin Pearson, PhD
Francis Feltner, DNP, MSN, RN, FAAN
Hong Huang, MD, PhD
Brandon Schanbacher, MS
John Flunker, PhD