Oversight of Collaborative Research
For many years, multi-site research also entailed multiple site-specific IRB reviews. However regulatory changes have sought to streamline the process of submitting and reconciling multiple, independent reviews. As of January 2020, the OHRP Common Rule has stipulated that multi-institutional studies shall be reviewed by a single IRB of record.
IRB directors and IRB leadership from HCSRN research institutions have been collaborating to form an HCSRN IRB work group since 2010. The HCSRN IRB work group had worked to develop a streamlined reciprocal IRB review process and Inter-Institutional Agreements starting in 2011. In recognition of further administrative streamlining opportunities and mechanisms now available, the HCSRN IRB workgroup has “retired” their reciprocal review agreement. Effective January 1, 2020, the HCSRN IRBs are utilizing the SMART IRB Platform to manage and adhere to the oversight provisions for multisite research.
The HCSRN IRB workgroup meets every other month to collaborate and share best practices. This group is led by Melissa Goff, Kaiser Permanente, and Paula Tebeau, Harvard Pilgrim Healthcare. Please feel free to reach out to Melissa (email@example.com) and/or Paula (firstname.lastname@example.org) if you have any issues or questions related to IRB review of HCSRN research.