Yes. If the SMART IRB Standard Operating Procedures are being followed for a study, the study team must first disclose this potential financial conflict of interest (COI), as well as any applicable management plans, to their institution’s Point of Contact (POC), who will then assess whether the COI impacts their decision to cede IRB review. If the POC determines that the study can continue to be ceded to the Reviewing IRB, the study team from the Relying Institution is responsible for disclosing the COI and any applicable management plans to the Lead Study Team (LST), or designee. The LST (or designee) will then inform the Reviewing IRB so that the IRB can determine how to address the potential conflict in regard to the study under its purview.
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)?