The NEW application and protocol form is designed to assist the IRB in identifying which activities in a multi-center study will be conducted by OSU researchers. Researchers should complete the relevant sections of the new application and protocol form (see Step 3 under Preparing an Initial Submission) if:
1) A protocol from an external institution is being submitted in lieu of the OSU protocol template, or
2) When the researcher is requesting that OSU defer oversight to an external IRB.
External Collaborators and IRBs
All investigators on the study team must be covered by an IRB approval regardless of their affiliation with OSU. To determine which investigators need to be listed as part of the study team, please see “When should I list collaborators as study team members?” decision tree.
There is a mechanism in place for one IRB to defer oversight to another. This reduces the need for multiple IRBs to review a single study. Most IRBs, but not all, are willing to facilitate this process. Therefore, there are three options for ensuring that investigators from multiple institutions are covered by an IRB approval for a single study:
1) The OSU IRB can defer oversight to an external institution
2) The OSU IRB can accept responsibility for oversight of external researchers
3) Each institution can oversee the research separately (except for non-exempt, NIH-funded research)
IRB Office staff will help OSU researchers navigate these decisions by speaking directly with the external IRBs. If there are external collaborators, please provide appropriate contact information for the IRB at the collaborator’s institution in the new application and protocol form. The Collaborating with an External Institution decision tree also provides information on the steps taken when collaborating with another institution.
Once a deferral arrangement is in place, researchers are responsible for ensuring that all IRBs have the same documentation. If OSU is the IRB of record, the OSU approval notice and approved documents should be submitted to the external IRB(s) by the external collaborator(s). If OSU is deferring oversight to an outside IRB, the OSU PI is responsible for ensuring that the OSU IRB has all study documents, approvals, continuing reviews, revisions, etc. related to the project.