Baystate Health has entered into collaboration with the National Cancer Institute Central Institutional Review Board (CIRB) for cooperative group projects. The CIRB Initiative is a partnership between the NCI CIRB and local institutions based on the signed Authorization Agreement and Division of Responsibilities document.
The CIRB conducts all IRB reviews of selected NCI-sponsored trials. The CIRB also reviews local context considerations pertaining to Signatory Institutions and their Signatory Institution Principal Investigators for the NCI trials opened at the institution using the CIRB.
IRBshare is a joint IRB review model for multi-site studies that provides a mechanism to streamline IRB submission and the IRB review process at all phases of IRB review through sharing of and reliance on IRB-approved documents between IRBs.
This joint review model has acknowledgement from OHRP, FDA, and AAHRPP and benefits research studies by reducing duplication of effort for review boards and researchers, facilitating faster study start-up, promotes transparency and consistency between IRBs and encourages communication and education.
SMART IRB is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.
SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and intended to serve as a roadmap for institutions to implement The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research.
The Tufts CTSI was established in August 2008 with a grant (The Clinical and Translational Science Awards, CTSA) from the National Institutes of Health (NIH).
Tufts CTSI’s promotion of collaborative, cross-disciplinary, full-spectrum translational research will have a substantial impact on how research is done, at Tufts and beyond. The CTSI reflects Tufts' unique emphasis on community in biomedical research by including multiple hospitals and health plans, industry leaders, community organizations, and other participants who share our vision, in Massachusetts and nationally.
The Tufts CTSI spans all the schools of Tufts University, its affiliated hospitals across Massachusetts and Maine, participating universities, community organizations, and non-profit and for-profit organizations. The Tufts CTSI is the home of support and education aimed at transforming research across all its participating organizations. This includes the CTSI Portal and the MS/PhD Clinical Research Program at the Tufts University Sackler School of Graduate Biomedical Sciences.
With the University of Massachusetts Amherst nearby, Baystate Medical Center is able to take advantage of the full research capabilities of a major research university to engage in biomedical translational research.
Baystate Medical Center and the University of Massachusetts Amherst have partnered to create the Pioneer Valley Life Sciences Institute, an independent biomedical research institute located in Springfield that fosters interdisciplinary and inter-institutional research.
WIRB provides review services for more than 400 institutions and their affiliates (academic centers, hospitals, networks, and in-house biotech research), as well as individual investigators, nationally and internationally. These long-standing institutional relationships give them deep knowledge of unique investigator requirements and established consent language for different institutions, enabling us to develop efficient processes for comprehensive, streamlined reviews. WIRB representatives are there to answer questions and exchange information about research protocols, regulations, submission requirements.
Baystate Health has chosen to outsource industry-sponsored research reviews to WIRB in an effort to accelerate review turnaround time, reduce costs incurred by review delays, and provide the expertise needed to review any protocol.