Institutional Responsibilities
Although the sIRB mandate streamlines IRB review, it does not eliminate the participating institutions’ many other responsibilities for oversight of human subjects research. Each institution remains responsible for:
- researcher training
- conflict of interest disclosures
- HIPAA
- conducting ancillary reviews such as IBC or radiation safety
- compliant research conduct
- maintaining oversight with respect to state and local laws and other institutional policies
Communication Plan
Consistent communication between the lead site and all participating sites is the key to successfully conducting a multi-site study. The NIH policy allows awardee institutions to decide who will be responsible for managing communications to the participating sites. Whoever is responsible for communication will require processes to manage and document the exchanges. Some institutions have IRB systems that automatically send notices of approval and updates to all sites. Most academic institutions do not have IRB systems capable of this level of communication. Ohio State’s Buck-IRB system is not structured to enable external sites to submit event notices or receive approval notifications. Instead, the responsibility lies with the principal investigator to have in place a communication plan and designated people to manage it. For communication plan guidance:
Institutional Profile and Study-Specific Local Context for Relying Sites
The Buck-IRB system is configured to enable management and review of multi-site research. The system features an upload box for local context worksheets and site-specific documents. Ohio State's local context survey template enables the IRB to obtain additional information about participating relying sites in multi-site research studies. The worksheet collects information to create an institutional profile about collaborating sites and study-specific considerations such as local laws that may affect the conduct of research. This form should be submitted when the participating site will recruit or obtain consent from research participants, or if any research interventions or participant interactions will occur at the site.
Forms and Resources
IRB Authorization Agreement – FWA Holding Institutions
The IRB Authorization Agreement (IAA) authorizes a FWA holding institution who is not a SMART IRB participating institution to rely on an Ohio State IRB for review responsibilities. The IAA OHRP template describes the division of responsibilities between the relying institution and the Ohio State IRB.
IRB Authorization Agreement – SMART IRB Participating Institutions
Ohio State prefers to use the SMART IRB Online Reliance System or the Ohio State SMART IRB Letter of Acknowledgement template for SMART IRB participating institutions who rely on an Ohio State IRB.
Letter of Support
Email IRBAgreements@osu.edu to request a letter of support and/or a single IRB plan for grant submission purposes. Include the study title, PI name, name(s) of any collaborating institution(s), and confirmation that the collaborating sites are willing to rely on Ohio State’s review.