Under the SMART IRB Agreement, the Reviewing IRB is required to promptly notify the Overall PI, Site Investigators, and Relying Institutions of any finding of serious and or/continuing noncompliance or of apparent serious and/or continuing noncompliance with applicable human subjects protection regulations or with the requirements or determinations of the Reviewing IRB pertaining to the Relying Institution or its Research Personnel or pertaining to another institution if such finding relates to or may affect the conduct of the research study or the rights or welfare of human subjects participating in the study at the Relying Institution. In addition, the Reviewing IRB will communicate the steps it deems necessary for remediation of the noncompliance. The Reviewing IRB also will determine whether any federal agencies must be notified, such as the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), based on study funding, status of the Federalwide Assurances for the Relying Institution(s) involved (e.g., whether institutions have “unchecked the box”), and whether the study falls under FDA 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)?