Under the SMART IRB Standard Operating Procedures, if any study team members from a Relying Institution have a potential conflict of interest (based on their institution’s policies) that is relevant to the study, this potential conflict and any related management plans must be reported to their institution’s Point of Contact (POC) and to the Lead Study Team (LST), or LST designee. The LST is responsible for informing the Reviewing IRB of this information, so that the IRB can determine how to address the conflict. The Reviewing IRB will ensure the Relying Institution’s management plans are applied and can impose additional requirements above and beyond those of the Relying Institution’s.
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)?