Question:

Does the IRB have a policy statement on reporting requirements for adverse events and serious adverse events?
– Regulatory manager, clinical research site

Response: 

In 2009, FDA published guidance to address the expressed concern by the IRB community that that “increasingly large volumes of individual adverse event (AE) reports submitted to IRBs—often lacking in context and detail inhibited, rather than enhanced the ability of IRBs to protect human subjects.” Through this FDA guidance document, the FDA encouraged efforts by investigators and sponsors to ensure that IRBs receive “meaningful AE information”.

Consistent with FDA Guidance, WCG IRBs require reporting of adverse events only when the adverse event or IND safety report requires a change to the protocol or consent document.  

For protocols approved by WCG IRBs, reporting requirements are defined in the WCG Policy HRP-071. The WCG submission form, Promptly Reportable Information, also provides a list of reportable events to help research sites and sponsors determine when reporting to the IRB is required.

WCG IRBs also require reporting of the following events:

  • Unanticipated adverse device effect
  • New or increased risk 
  • Protocol deviation that harmed a subject or placed subject at risk of harm 
  • Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a subject
  • Audit, inspection, or inquiry by a federal agency 
  • Written reports of federal agencies (e.g., FDA Form 483)
  • Allegation of Noncompliance or Finding of Noncompliance 
  • Breach of confidentiality 
  • Unresolved subject complaint 
  • Suspension or premature termination by the sponsor, investigator, or institution 
  • Incarceration of a subject in a research study not approved to involve prisoners
  • State medical board actions against physician researchers
  • Information where the sponsor requires prompt reporting to the IRB 

Note that adverse event reporting requirements may vary across IRBs; so, be sure to check with the IRB of record for your protocol to determine what must be reported.