Extramural Investigator Research Collaboration Core

As a National Biocontainment Laboratory the NEIDL will provide access to high containment laboratories, BSL-3 and BSL-4, as well as access to both scientific and administrative cores to extramural investigators. Extramural investigators will include those from both academic and commercial entities whose research has progressed to the stage where use of the wild type agent is required. For example, in vivo challenge studies for the determination of vaccine and/or therapeutic development efficacy would be an appropriate phase for engagement of the Collaborative Research Group cores. In the case of the development of diagnostic tools it is envisioned that these methods will have developed to the point of requiring live select agent evaluation. While initial thoughts were focused on the concept that external investigators would travel to the NEIDL and remain for extended periods of time in order to personally conduct experiments, we now realize that this is impractical for the following reasons: Approval for select agent research is restricted to the home institution or entity where the extramural investigator is employed, and select agent approval may not be transferred therefore substantial delays in the research progress would result from having extramural investigators meet select agent registration requirements; In order to gain access to the NEIDL high containment laboratories, individual investigators will have to meet the training requirements of Boston University / Boston Medical Center and demonstrate competence for this work prior to gaining access to the facility. All investigators will be required to successfully complete a rigorous training program in the BSL-4 simulator and demonstrate competence for research at this level of containment. While this training course is currently under development, it is envisioned to be a three to four week intensive course. Relocating a team of investigators from outside institutions or companies is logistically challenging and many investigators do not want to be away from their home institutions or companies for extended periods. We have had numerous discussions with directors of the Regional Centers of Excellence in Emerging Infectious Diseases and companies who have all indicated that it would be preferable to have resident teams of investigators who are devoted to collaborative projects. Thus both we and our potential collaborators believe the most efficient manner to host the research from extramural investigators is to establish at least 2 Collaborative Research Group Cores (CRG). These cores will consist of teams that will be dedicated to the hands on execution of all extramural research conducted at the NEIDL. We anticipate that at least two such CRG cores will be required. Importantly, these teams will be guided from the scientific standpoint by the extramural investigator who will either be on site at the NEIDL for the duration of this work, direct their research on a daily basis from their respective home institution, or a combination of the above. Since the research teams in the Collaborative Research Group Cores will be employed by the NEIDL, they will already have Select Agent clearance from Boston University / Boston Medical Center, and will have successfully completed the NEIDL high containment training program.

Functions and Services

Each team in the Collaborative Research Group Core will be constituted to provide the services needed to appropriately conduct the research program of the extramural investigator/team. While the CRG team will have general experience with research with agents that require high containment, we envision that a given team will interact with other scientific cores to meet the individual demands of an extramural investigator. For example, were an extramural research program to be focused on aerosol challenge experiments, the CRG team would liaison with the aerosol challenge core expertise.