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. The IHSFC will provide bidirectional project support. The Center anticipates that there will be cases where basic scientists may want to extend investigations to human trials, and is also expected to have human studies, or research questions identified by the Community Engagement Core (CEC), to stimulate non-human studies. The IHSFC will enable and enhance both of these arenas by providing access to personnel and related resources in hope of minimizing 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.
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.
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.