No, the IRB at the Overall PI’s institution is not required to be the Reviewing IRB for that study. However, the Overall PI’s home IRB has the right of first refusal to serve as the Reviewing IRB and will typically be identified as the Reviewing IRB by default, unless another Reviewing IRB has already been pre-determined by a study sponsor or grant, the Reviewing IRB has already been established by prior arrangement (e.g., a network central IRB), or an IRB is determined to be a more appropriate Reviewing IRB for a particular study (e.g., based on type of procedures to be performed, subject population, or other criteria).
Articles in this section
- What laws and regulations must the Reviewing IRB consider?
- What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
- Who is responsible for addressing a subject's complaint?
- If one of the Relying Institutions does not submit the necessary information for continuing review in advance of the expiration date, will all Relying Institutions be affected?
- If the Reviewing IRB requests an audit of a study conducted at a Relying Institution, will the Relying Institution receive documentation that the audit was conducted, regardless of the result?
- Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
- Who is informed when the Reviewing IRB makes a determination of serious and/or continuing noncompliance or suspends or terminates a study?
- What if an amendment could be affected by state law or other local institutional requirements?
- How is it ensured that all study teams are aware of new amendments and know when the Reviewing IRB has approved them?
- Does the Relying Institution have a role in the review of amendments (changes of protocol)?
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