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)?