If the SMART IRB Point of Contact at the Overall PI's home institution (HI) reviews a request to serve as the Reviewing IRB and declines to serve as the Reviewing IRB for all Participating Institutions, the HI POC will then determine whether the HI is willing to cede review to another institution to serve as the Reviewing IRB for the Overall PI. If the HI is unwilling to cede review to another institution, the HI IRB proceeds to conduct a review of the study for its own study team or declines to participate in the research. The other Site Investigators are referred to new potential Reviewing IRBs identified by the Overall PI or by the HI POC. If the HI declines to serve as the Reviewing IRB for the study but is willing to cede review to another institution, the HI POC contacts potential alternate Reviewing IRBs identified either by the Overall PI or in advance. The Overall PI may participate in this process where necessary. Once the Reviewing IRB has been established, the SMART IRB POC (on behalf of the Reviewing IRB) will notify the Overall PI of the decision.
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)?