At Advarra, we often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. This leaves it up to individual IRBs to establish a definition, policies/procedures, and reporting requirements that sponsors, CROs, and investigative sites are required to follow. Understandably, this can cause confusion for researchers who work with multiple IRBs, so it’s important to make sure you’re familiar with your IRB’s reporting requirements—and if you’re not sure, it’s always appropriate to reach out to the IRB for clarification.
Here are the definitions Advarra’s IRB has established:
- Noncompliance is any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with applicable regulations, the IRB’s Handbook, and/or the determinations and requirements of the IRB.
- Noncompliance may range from minor to serious; be unintentional or willful; and may occur once, sporadically, or continuously.
- The degree of noncompliance is evaluated on a case-by-case basis and takes into account whether subjects were harmed or placed at an increased risk of harm.
- Serious noncompliance is defined as any action or omission in the conduct or oversight of research involving human subjects that affects the rights and welfare of subjects, increases risk to subjects, or compromises the scientific integrity or validity of the research.
- Continuing noncompliance is defined as a pattern of repeatedly failing to comply with applicable regulations, the IRB’s Handbook, and/or the determinations and requirements of the IRB that may affect subjects’ rights and welfare, increase risk to subjects, or may compromise the scientific integrity or validity of the research.
- Continuing noncompliance also includes frequent instances of minor noncompliance or failure to respond to a request to resolve an episode of noncompliance.
Consistent with other reportable events, Advarra expects noncompliance reports be submitted as soon as possible, no later than 2 weeks or 10 business days from the time of the event.
In addition to reporting the noncompliance event, some IRBs may require the report to also include information like the immediate action that was taken to ensure subjects were not harmed, a corrective action plan (to prevent re-occurrence of the event), and supporting information from other sources if applicable. Again, check with your IRB to understand the specific reporting requirements. When working with Advarra, your best source for this kind of information is the IRB Handbook, available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform.
Reports and allegations of noncompliance will be evaluated by the IRB and can result in an action up to and including suspension or termination of IRB approval. Any report of noncompliance determined by the IRB to be serious or continuing or determination to suspend or terminate IRB approval will be reported to the appropriate regulatory agency.
When in doubt, it’s best to report noncompliance concerns to the IRB and allow it to make an appropriate determination to ensure the rights and welfare of research participants are adequately protected.
Need more information on IRB reporting requirements? Check out our blog Reporting to the IRB: Unanticipated Problems and Serious Adverse Events (SAEs) in Drug Studies.