To enhance the impact of clinical and translational research conducted at Yale University and Yale New Haven Health System (YNHHS), the two entities have launched a ‘One IRB’ project to align processes, policies and procedures as they relate to human subjects research, including the Institutional Review Board (IRB) review.
As a result of this initiative, all human subjects research conducted at YNHHS will be under the purview of the Yale University Human Research Protection Program (HRPP) and all YNHHS research will be reviewed by the Yale University IRB. The HRPP will also review submissions for studies reviewed by external (non-Yale IRBs) e.g., when a review by a central IRB is required or preferred.
There are several advantages to moving to One IRB. The standardized submission and oversight of research will benefit all research subjects and researchers. One IRB will also increase access to clinical trials and diversity of enrollment. Additionally, as regulatory issues related to research continue to evolve and become more complex, there will be one focus of expertise to scale systemwide.
An effective date for submitting new studies to the Yale University HRPP for IRB review is still being determined, but the change is anticipated to occur early this year. The transfer of existing studies currently under the purview of the Bridgeport IRB is anticipated to begin in April 2024.
YNHHS investigators, research staff, and other stakeholders are encouraged to attend one of the training sessions on the IRB submission processes. Learn more about the Yale Human Research Protection Program and Yale IRB.
To ensure that YNHHS investigators and partners receive support, the Yale University HRPP will designate a member of its staff to serve as the primary point of contact for YNHHS investigators. In the interim, questions and concerns related to the transition can be sent to Linda Coleman, HRPP director, at [email protected] or Monika Lau, HRPP assistant director, at [email protected].
